MANUAL
National Repository for Medicinal Products
Author: Mariann Fallmark,
Medical Products Agency
Sign.:
Version:
Page:
3.4
1(31)
Valid from: 2007-06-28
Replaces: 3.3
NPL – National Repository for Medicinal Products
instructions for reviewing and
verifying details in the NPL
1
National Repository for Medicinal Products
MANUAL
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HISTORY / VERSION HISTORY
Date
2002-12-20
2003-01-22
2003-02-09
Version
0.1
0.2
0.3
2004-03-30
2004-04-02
2004-04-14
2004-04-29
2004-05-13
2004-05-27
2004-06-02
2004-12-09
2005-02-04
2005-02-2 1
0.4
0.5
0.6
0.7
0.8
1.0
1.1
2.0
2.1
2.2
2006-03-10
2006-07-07
2006-11-10
2006-12-05
2007-06-28
3
3.1
3.2
3.3
3.4
2
Reason/author
New document/Bengt Dahlberg
Changes following review
Corrections following pilot testing and evaluation. Some elements added to
interface but not included in this version/Bengt Dahlberg
Edited following restart of project/Bengt Dahlberg
Edited following internal review/Bengt Dahlberg
List of elements rewritten following internal revision/Bengt Dahlberg
Completion of new interface in accordance with interface review version 0.8
Changes following internal and external review/Mariann Nilsson
Version changed to 1.0. New Screenshot 1.
New Screenshots 6 and 7 and Table 1.
Revision/Mariann Nilsson
Addition of instructions and a further login screenshot/Mariann Nilsson
Logo, user admin., delete/remove and addresses, NPL v2.2.1 (next price), new
information about information flow between companies and Apoteket AB/MN
Adjustment for NPL v3, parallel distribution and validation checks
Warning messages
EAN text changed
Withdrawal of MA
Question itemnumber
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CONTENTS:
1 INTRODUCTION ........................................................................................................................... 4
1.1 PURPOSE AND SCOPE ................................................................................................................... 4
1.2 DEFINITIONS AND ABBREVIATIONS.............................................................................................. 4
1.3 REFERENCES ............................................................................................................................... 5
2 COMPILING PRODUCT INFORMATION FOR REVIEW AND VERIFICATION ........... 6
3 USER ADMINISTRATION........................................................................................................... 6
4 THE REVIEW AND VERIFICATION PROCESS .................................................................... 8
4.1 PRODUCT STATUS AND ITS INFORMATION ELEMENT .................................................................... 9
5 INFORMATION TO BE REVIEWED/VERIFIED .................................................................... 9
6 THE NPL WEBSITE .................................................................................................................... 18
7 LOGGING IN AND THE PRODUCT REPORT ...................................................................... 19
7.1 LOGGING IN ............................................................................................................................... 19
7.2 THE PRODUCT REPORT ............................................................................................................... 21
7.3 VALIDATION CHECKS ................................................................................................................ 24
7.4 WARNING MESSAGES ................................................................................................................ 26
7.5 CHANGES .................................................................................................................................. 27
7.6 ERROR REPORTING .................................................................................................................... 28
8 ONGOING CHANGES IN THE NPL ........................................................................................ 28
8.1 NEW PRODUCTS ......................................................................................................................... 29
8.2 PRICE CHANGES ......................................................................................................................... 29
8.3 WITHDRAWAL OF PRODUCTS ..................................................................................................... 30
8.4 OTHER CHANGES ....................................................................................................................... 30
8.4.1 Change of item number .................................................................................................................................. 30
8.4.2 Suspension of ordering ................................................................................................................................... 30
8.4.3 Barcode (EAN code)....................................................................................................................................... 31
8.5 INSTRUCTIONS ........................................................................................................................... 31
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1 INTRODUCTION
1.1 Purpose and scope
The purpose of this document is to describe how medicinal products companies must review and verify
information in the NPL. The document describes briefly how information is brought together in the NPL from
various information sources, and how medicinal products companies can access this information electronically
with facilities for reviewing, commenting on, changing and ultimately verifying the information in the NPL.
The NPL covers all approved medicinal products, even those not marketed in Sweden including those withdrawn
after June 2004. Neither licensed medicinal products nor prescribable consumables covered by the Swedish
benefits system are included in the repository.
Parallel-imported medicinal products must be reviewed and verified in the same way as the original products.
Parallel-distributed packs of centrally approved products must also be reviewed and verified by the parallel
distributor (which is a company other than an MAH). These packs include those for original products, the MAH's
packs and other parallel distributors' packs. Companies can change only their own packs, and only an MAH can
change information at the product level (see Ch. 9 for how to change information).
1.2 Definitions and abbreviations
Terminology
ACA
Element
FLIS
Review
LIF
LV
LVIS
LFN
NPL ID
Verification
Verified product
Interface
4
Description
Apoteket's Central Article Repository. The system that forms the basis for
the IT processing of all Apoteket AB's product information.
A specific piece of information, e.g. name of medicinal product,
constituting a part of the total information.
The Pharmaceutical Benefits Board's Medicinal Product Information
System
Phase of work in which companies compare information in the NPL with
their own internal information to confirm that the information in the NPL
agrees with their own.
Swedish Association of the Pharmaceutical Industry
Medical Products Agency
The LV Information System
Pharmaceutical Benefits Board
NPL ID (unique product identification). Set by LV when a new
application for approval is made.
Following review, the phase of work in which the company approves the
information in the NPL by changing the product's status from "not
verified" to "verified".
Product that has been reviewed, corrected if necessary and approved by
the company.
Screen display (application) for reviewing and verifying product
information in the NPL.
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1.3 References
Ref. No.
Doc. No.
Document Name
Version No.
1
1–5
The NPL's instructions
2.0
5
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2 COMPILING PRODUCT INFORMATION FOR REVIEW AND
VERIFICATION
To create a National Repository for Medicinal Products, existing information from various principals must be
assembled in a single repository. The information in the NPL comprises information available in the information
systems of the Medical Products Agency (LVIS), the Pharmaceutical Benefits Board (FLIS) and the Apoteket
Central Article Repository (ACA). Each organisation is responsible for the information it holds and that must be
included in the NPL being transferred to the NPL.
After the information has been assembled in the NPL, the company responsible for each product has the opportunity
to review and verify the information. Information is updated constantly, so reviews must take place regularly. This
creates an up-to-date and quality-assured repository of information about medicinal products.
At the start of a review, all products have "not verified" status. The review includes the medicinal products
company quality-assuring (in terms of correctness) the information about its products in the NPL. Once the review
and any corrections to information have been completed, the company changes the product's status from "not
verified" to "verified". The company is responsible for carrying out the necessary changes to the information
elements it owns in the NPL. If during the review the company discovers errors in elements owned by the LV, the
LFN or Apoteket, the company must inform the organisation in question.
3 USER ADMINISTRATION
The user with the highest authority in the NPL is called the "NPL administrator" and is located at the LV. The
NPL administrator is authorised to create new entities at all three levels in the NPL (see Fig. 1). On the nexthighest level there are four principal entities: the LV, the LFN, Apoteket and the Pharmaceutical industry. Each
principal entity is authorised to define its own administrators within its own area. These administrators are
authorised to add organisations or administrators for organisations within their respective principal areas, e.g. the
administrator for the medical products industry (in the LIF) is authorised to add a new medicinal products
company and an administrator linked to this company. Each company's administrator can then create users that
will participate in the review. The medicinal products companies co-ordinate their authorisations in the LIF's Fass
database (see Fig. 1).
There are two different types of users of the NPL: administrators and users. Administrators are authorised to create
both new administrators and users on their level, e.g. an administrator in a medicinal products company can create
new users or administrators within his/her own company. If the same person is to be an administrator for several
companies, an administrator identity is required for each company.
NPL administrator
LV
LFN adm.
Apoteket adm.
Comp. 1 adm.
Company 1 user 1
6
LIF
Comp. 2 adm.
Company 1 adm. 2
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The NPL has only one administrator, located at the LV. There are four subordinate administrators, each authorised
to create new users within their respective organisation. The LIF administrator creates one administrator at each
company participating in review and verification. In turn, the administrator within each company is authorised to
create new users that will participate in review/verification at the company.
Each defined user within a company can view and verify only products from companies they are authorised to
view. The list of products to be reviewed and verified by each company is defined by its role as an MAH or
Agent. A product with both an MAH and an Agent is reviewed and verified by the Agent, in which case the MAH
therefore has no access to the product. A product with only an MAH, and no Agent, is registered, checked and
verified by the MAH.
Once you have logged in to "User administration", B in Screenshot 1 is displayed:
All users within the company are listed with their roles, i.e. "admin" or "user". "Remove" removes the user. The
"Edit" option is used to change the user's various parameters, e.g. name, whether active, role, start/expiry dates or
password.
The "Add existing user" option displays a list of the company's existing users that can be added.
The administrator can create new users with the "Add user" option.
After the new user's details have been entered, clicking "Save" saves the user in the NPL and links him/her to the
current company. It also enables the user to be added to other companies. Note that the e-mail address identifies the
user, and can therefore occur only once in the system.
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4 THE REVIEW AND VERIFICATION PROCESS
Product information is reviewed and verified using software provided by the LV via the Internet. This software
contains an interface where companies can review product information in the NPL. Companies can also change
certain information and ultimately verify the information by changing the status of a medicinal product to
"verified".
The interface is provided by the LV and is accessible on a server to which companies can connect.
Communication takes place via secure log-in. In addition to the review and verification interface, there is also a
user administration interface. This is used to add, remove and change users in companies reviewing/verifying
information in the NPL.
A complete list of the elements included in the NPL and that must be reviewed is given in Table 1. The Table also
includes a description of each element's owner and whether companies can change the element directly in the
interface. The user administration and review software is Web-based, so popular browsers such as Internet
Explorer can be used. Chapters 7 and 8 describe how to correct information.
Product information can be reviewed and verified only after logging in. If users have access to several companies'
products, after logging in they must select the company whose products they want to work on. The products
belonging to that company, in its capacity as an MAH or Agent, are then displayed. A simple search tool is
available for selecting from the available products. Searching can be done either by the product's name (start of
name is sufficient) or its NPL ID.
The product information is displayed in separate fields, each with its own heading (see Chap. 7.2, Screenshot 4).
Review/verification involves going through the information displayed in the NPL and ensuring that it agrees with
the company's information. Any incorrect information must be changed. There are two ways of doing this. If the
incorrect information is owned by the company and the change does not require special permission from the LV,
the information can be corrected directly in the interface. If the incorrect information is owned by another principal,
e.g. Apoteket, a separate comment must be sent to that principal containing the incorrect information and the
product identity. The matter must then be considered by the owner concerned and corrected if necessary. See also
Chapter 10, Reporting errors.
Company
Yes, mark as
verified
Verify NPL
product info
OK
No, change in
NPL
Create a
variation
application
Apply for
variation
No, request
change
LV
Is it a
variation?
Request
application
No
Other errors?
Correct
LVIS
Update
LVIS
Transfer to
NPL
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When a user has logged in to the NPL, the company's products are displayed and review/verification can begin by
comparing the information with that held by the company. If the information matches, the company can verify it
immediately by changing the product's status to "verified". If the information does not match, the company makes
the changes directly in the interface or sends a request for a change to the appropriate principal. After the change
has been made, the company can verify the information.
4.1 Product status and its information element
A. If the product status is "Not verified" but all the information is correct, the company marks the product as
"Verified" by clicking "Yes, set verified". If corrections are required subsequently, "No, correct errors" is clicked
and then the change is saved with "Yes, save changes". The product status then changes to "Changed". If the
changes are not to be saved, "No, discard changes" is used. The product status will then remain "Not verified".
B. When the product status is "Changed", the company can choose to verify the information using "Yes, set to
verified". The product status then changes to "Verified". The company can also choose to make further changes
for a product with status "Changed" using the "No, correct errors" function. The product status stays "Changed"
until the company chooses the "Yes, set to verified" function.
C. A product whose status has changed to "Verified" can be returned to "Changed" status using the "No, set not
verified" function. To change the product status from "Changed" to "Verified", use the "Yes, set to verified"
function.
5 INFORMATION TO BE REVIEWED/VERIFIED
Table 1 below contains a list of the elements included in the NPL information review/verification interface. The
list does not include all the elements in the NPL, but only those included in review/verification. Some of the
elements take values from a predefined list, e.g. Pharmaceutical form, in which the majority of values are
predefined in Standard Terms.
In Table 1 there is a reference to a number (Screenshot no.) indicating the corresponding element in the interface
(Screenshot 4).
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MANUAL
National Repository for Medicinal Products
Table 1
Element in interface
Trade name
Owner1 Can be Screenchanged shot no.3
in IF2
C
No
1
Previous name
C
No
2
Pharmaceutical form
LV
No
3
Strength, alphanumeric
LV
No
4
Strength, numeric
C
Yes
5
Unit
C
Yes
6
Product type
LV
No
7
Approval date
LV
No
8
Withdrawal date
LV
No
9
ATC code
LV
No
10
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Description
Name of product in accordance with approval
obtained from the LV, available from the LVIS.
Any previous name in full. State the product's
previous names in the market,
obtained from the LVIS.
State the product's pharmaceutical form as
approved, acc. to Standard Terms.
Strength in full text. Has both numeric part and
unit. Strength in full text is obtained from the
LVIS.
The reason for the division into 'Strength,
alphanumeric', 'Strength, numeric' and 'Unit' is
that certain prescribing modules base their
functionality on such a division. Showing the
strength of combination products correctly
requires it to be stated as 'Strength, alphanumeric'.
Strength, numeric part. The information has been
preloaded from Apoteket AB. NOTE: for
combination products that include several active
substances of different strengths, this element
must be left empty.
Unit for numeric strength. The information has
been preloaded from Apoteket AB. The unit can
take values only from a predefined list. NOTE: for
combination products that include several active
substances of different strengths, this element
must be left empty.
States product type, e.g. medicinal product or
extempore. Can take values only from a
predefined list.
Date when product was first approved for sale. Set
by the LV in conjunction with the approval.
Format is yyyy-mm-dd.
States expiry date of product approval, provided
the company has notified this in advance. Format
is yyyy-mm-dd.
ATC code. Anatomical Therapeutical Chemical
classification in accordance with the code set on
approval by the LV. The ATC code can take
values only from a predefined list.
"Owner" means the entity responsible for the content of the information. C = Company, A =
Apoteket AB, LV = Medical Products Agency, LFN = Pharmaceutical Benefits Board..
2
Whether the company can change information directly in the interface (IF) without contacting the
LV or any other organisation.
3
Reference to Screenshot 7.
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Parallel-import country
Owner1 Can be Screenchanged shot no.3
in IF2
LV
No
11
Parallel-import deviation
LV
No
Product notes
C
Yes
Approval procedure
LV
No
Medicinal product form,
properties
A
No
Swedish approval number
LV
No
NPL ID
LV
No
Contains latex
C
Yes
Interchangeable
LV
No
Permission for dose dispensing LV
No
Driving warning
LV
No
LV sales stop
LV
No
Contains lactose
C
Yes
Element in interface
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Description
States country from which the medicinal product
is parallel imported. Can take values only from a
predefined list.
12
Deviation states how the parallel-imported
medicinal product differs from the original
product. May involve markings on tablets, etc.
13
Product notes refers to free text that the company
may use. For example, this could concern
information that the product is not intended to be
marketed in Sweden.
14
Type of approval procedure used for the product's
most recent approval.
15
Properties of the medicinal product form contains
a detailed description, above all of the
commodity's properties.
Not currently used.
16
Swedish approval number. Issued by the LV.
Synonymous with registration number. Has an
additional zero (0) at the end for data processing
reasons. Also, centrally approved products have a
Swedish "approval no." for use in Sweden.
17
The NPL ID is a unique identifier for the product.
Set by the LV when an application for approval
has come in.
18
This marking states that latex residues may be
present in the product. It applies above all to
injectables, where rubber stoppers, etc., that
include latex may come into contact with the
product. The information is derived from the
corresponding element at the pack level. This
field cannot be edited.
19, 74, 75, States whether the product is interchangeable with
76
another product when dispensed at the pharmacy.
This is stated with the value Yes or No. If the
product is interchangeable, the interchangeability
group to which it belongs is evident from the
substance, pharmaceutical form and strength
groups.
20
Permission for dose dispensing means that there is
general permission for the product pack to be
broken for dose dispensing. This permission is
granted by the LV on special application.
21
States whether the product's SPC has a warning
about driving.
22
States whether sales of the product are
temporarily stopped by the LV. The product is
still defined as approved, but sales have been
stopped by the LV for some reason.
23
This marking states whether the product contains
lactose. The information is preloaded on the basis
of the product's composition in the LVIS.
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Marketed (prev. Available)
Owner1 Can be Screenchanged shot no.3
in IF2
C
Yes
24
Sold on prescription
LV
No
25
Special medicinal products
A
No
26
Control class
LV
No
27
Shelf life, dose disp.
LV
No
28
Form information
A
No
29
Pharmaceutical product
C
No
30
Amounts specified per
pharmaceutical basic entity
C
No
31
Element in interface
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Description
This field states whether a product is marketed in
Sweden. The information is derived from the
corresponding element for packs, where the
company must state whether they are available.
This field cannot be edited.
States whether the product is sold on prescription,
or whether some packs may be supplied OTC.
Sold on prescription can take values only from a
predefined list.
Concerns prescribing rules for other special
medicinal products in accordance with LVFS
1997:10, appendix 8. The information is
preloaded from Apoteket AB. Other special
medicinal products can take values only from a
predefined list.
States the product's narcotic class. The
classification follows the classification established
by the LV. Control class can take values only
from a predefined list.
Shelf life when broken states the product's shelf
life in months after the pack has been broken.
This shelf life is related to the permission for dose
dispensing given (see above).
General information about the form, e.g. if
strength information has been changed, the old
strength is given here. May also include
information about a specific material, e.g. acrylic.
Currently unused.
The name of the basic pharmaceutical entity
included in a medicinal product. No name is given
where the medicinal product consists of only one
entity. Where a medicinal product consists of
more than one entity, they are distinguished with
different names. For example, yellow tablet, white
tablet, blue tablet for certain contraceptive pills, or
powder and solution for an injectable fluid.
Obtained from the LVIS.
States how the amounts of the active ingredients
included relate to the composition, per
pharmaceutical product, per ml, per gram, etc.
Can take values only from a predefined list.
Obtained from the LVIS.
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Type of ingredient
Owner1 Can be Screenchanged shot no.3
in IF2
C
No
32
Substance
C
No
33
Amount
C
No
34
Max. amount
C
No
35
Amount unit
C
No
36
Additional unit
C
No
37
Chemical Abstract Service
Number, CASNO
C
No, the 38
LV
changes
on
request
by the
company
.
NPL pack ID
LV
No
Element in interface
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Description
States the ingredient's role in the composition, e.g.
active, inactive, colouring. In version 1.0 of the
NPL, only active ingredients will be declared.
Active ingredients may be active or active
equivalent. Where the active form is a salt, ester
or similar, the composition may be supplemented
by stating the active equivalent, which means the
amount of "pure" substance to which this
corresponds. Type of ingredient can take values
only from a predefined list. Obtained from the
LVIS.
Substance name in full text. INN, linked to
CASNO. The nomenclature used when stating the
name of the substance is obtained from the LVIS.
Numeric amount. States the quantitative numeric
component of a substance within a composition.
Obtained from the LVIS.
Upper limit where the quantitative numeric
amount is an interval.
Unit for numeric amount. States units for the
numeric amount stated in Amount. The amount
unit can take values only from a predefined list.
States how the amount and amount unit relate in
the composition. E.g. the stated amount is that
intended within normal variations or, if the
amount has not been stated, the additional unit can
take on the value Q.S., i.e. the amount necessary.
There may also be other variations. Can take
values only from a predefined list. The
information comes from the LVIS.
International unique identifier for chemical
substances. The LV has obtained this information
from the LVIS and transferred it to the NPL. The
LV has only transferred known CASNOs to the
NPL. CASNOs for substances can be found at the
following Internet address:
http://toxnet.nml.nih.gov/cgibin/sis/htmlgen?HSDB
NPL ID, unique identifier for each pack. Set by
the LV when an application for approval has
come in.
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Current item number
Owner1 Can be Screenchanged shot no.3
in IF2
C
Yes
40
EAN code
C
Yes
41
Previous item number
C
Yes
42
Pack size (text)
LV
No
43
Quantity multiple 2
C
Yes
44
Quantity multiple 1
Quantity, numeric
C
C
Yes
Yes
45
46
Quantity, numeric, unit
C
Yes
47
DDD per pack
A
No
48
Element in interface
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Description
This term contains an item number for each pack.
The item number for an approved medicinal
product is common to all Nordic countries. The
item number can be reused after being unused for
five years. The item number is therefore
unsuitable for use as the only repository
information in (e.g.) statistics. The information is
preloaded from the LVIS and then maintained by
the appropriate company. New packs that appear
after approval must be given an item number in
the NPL by the appropriate company.
Barcode in figures. GS1 article number (EAN
number) which is used for the barcode on the
pack. Shall comply with standards for EAN-13,
EAN-8, IFT-14 or GS1 128 codes. Apoteket AB
handles all of them but emphasises the use of
EAN-13 or EAN-8 codes.
Same as no. 40, but here the company can state
the previous item number if the pack has been
given a new one.
Quantity in full text. This term contains a
composite description of the pack size. This term
is used to give a simple description of the pack
size. The term can be used instead of Quantity
multiple 2, Quantity multiple 1, Quantity numeric,
Quantity numeric unit. The information comes
from the LVIS, and is the basis for the
information submitted when the product was
approved.
Where the pack consists of several units, these can
be specified with multiples. Some injectables have
packs containing 60 ampoules packed as six units
of ten ampoules each. Each ampoule contains 5
ml. In this case, 'Quantity multiple 1' is specified
as 10, 'Quantity multiple 2' as 6, 'Quantity
numeric' becomes 5 and 'Quantity numeric unit'
becomes millilitre. Where there are no multiples,
these elements are left empty. To define the pack
size, only information in Quantity numeric and
Quantity numeric unit is stated. The information
is preloaded from Apoteket AB and maintained by
the appropriate company.
See 'Quantity multiple 2', field 44.
Quantity in a numeric format, e.g. “98” if the pack
is a jar with 98 tablets. See 'Quantity multiple 2',
field 44 for description of pack size in numeric
format where there are several units in one pack.
Unit for the number in field 46, e.g. “pieces” or
“tablets”. Values obtained from a predefined list.
Defined Daily Dose per pack. Calculated as the
drug's strength multiplied by the pack contents
and then divided by the substance's DDD.
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Element in interface
Pack type detail
Owner1 Can be Screenchanged shot no.3
in IF2
C
Yes
49
AIP applies, not in benefit
scheme
C
Yes
50
Next AIP, not in benefit
scheme
C
Yes
51
Next AIP, not in benefit
scheme, date
AUP, not in benefit scheme,
excl. VAT
C
Yes
52
C
No
53
AUP, not in benefit scheme,
incl. VAT
AUP, prescription, not in
benefit scheme
C
No
54
C
No
55
AIP applies
LFN
No
56
AUP applies, OTC, excl. VAT LFN
No
57
AUP applies, incl. VAT
No
58
LFN
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Description
States type of pack. The information is preloaded
from the LVIS and maintained by the appropriate
company. The pack type detail can take values
only from a predefined list taken from the
European Pharmacopoeia's Standard Terms.
AIP = Pharmacy purchase price. Not in benefit
scheme means that the product is not included in
the pharmaceutical benefits scheme and that the
price has not been set by the LFN. Not included in
the review. The information will be preloaded
before start-up by Apoteket AB.
States next AIP. This element contains
information about the pack's next AIP. Stated in
combination with 'Next AIP, not in benefit
scheme, date'. Not included in the review.
Date when next AIP comes into force. Not
included in the review. Format is yyyy-mm-dd.
AUP = Pharmacy retail price. States that the
product is not covered by the pharmaceutical
benefits scheme. Calculated by the NPL based on
the formula supplied by the LFN. Not included in
the review.
See 'AUP, not in benefit scheme, excl. VAT'
The pharmacy retail price for the pack on
prescription. Concerns products not included in
the benefits scheme. Calculated by the NPL based
on the formula supplied by the LFN. Not included
in the review.
Apoteket's purchase price as determined by the
LFN for medicinal products and consumables that
are to be covered by the pharmaceutical
reimbursement scheme. Not included in the
review.
Apoteket's retail price determined by the LFN for
OTC medicinal products that if prescribed must
be covered by the pharmaceutical reimbursement
scheme. Calculated by the NPL based on the
formula supplied by the LFN. Not included in the
review.
Apoteket's retail price determined by the LFN for
ostomy products and medically related
consumables that if prescribed on the medical
devices prescription form must be covered by the
pharmaceutical reimbursement scheme.
Calculated by the NPL based on the formula
supplied by the LFN. Not included in the review.
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AUP applies, prescription
Owner1 Can be Screenchanged shot no.3
in IF2
LFN
No
59
Storage
LV
No
60
Storage method
LV
No
61
OTC
LV
No
62
Marketed (prev. Available)
C
Yes
63
Available from
C
Yes
64
Out of stock
C
Yes
65
Withdrawn from
C
No
66
Contains latex
C
Yes
67
Item properties
A
No
68
Item information
A
No
69
Item information
C
Yes
70
Restrictions
LFN
No
71
Element in interface
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Description
Apoteket's retail price determined by the LFN for
prescription products that if prescribed must be
covered by the pharmaceutical reimbursement
scheme. Calculated by the NPL based on the
formula supplied by the LFN. Not included in the
review.
Storage states the storage conditions for the pack,
e.g. opened pack. Can take values only from a
predefined list. Version 1.0 of the NPL includes
only general storage instructions. This means that
Storage can take only the value General from the
predefined list. Information obtained from the
LVIS.
Storage method is a summary of information
including shelf life and a unit for shelf life,
together with temperature. Units for shelf life and
temperature can take values only from predefined
lists. Information obtained from the LVIS.
Over the counter, i.e. whether the pack is
available without prescription. Information
obtained from the LVIS.
States whether the pack is available, and must
always be stated.
If the pack is not available, the company may
state a date when the pack is expected to become
available for sale. Format is yyyy-mm-dd.
States whether the company has stopped taking
orders for the pack, i.e. it is not available and
cannot be ordered from the wholesaler.
States expiry date for pack approval provided this
has been notified in advance by the company.
Format is yyyy-mm-dd.
This mark states that there may be latex residues
in the product in this pack. This applies chiefly to
injectables, where rubber stoppers and similar that
include latex may come into contact with the
product.
Item properties contains a detailed description of
the item's properties. For example, the description
could be 'large', 'unperfumed', 'blue'. The
information comes from Apoteket AB.
General information about the item. The
information comes from Apoteket AB.
The company's own full text information about
the item. For example, it could contain
information on availability.
States whether there are restrictions in relation to
an approved indication for a prescribed medicinal
product being covered by the pharmaceutical
reimbursement scheme. For example, the
pharmaceutical reimbursement scheme may apply
only to a specific indication or patient group.
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Organisations
Owner1 Can be Screenchanged shot no.3
in IF2
LV
No
72
Organisation's role
LV
No
73
Interchangeability - Strength
LV
No
74
Interchangeability - Substance
LV
No
75
Interchangeability Pharmaceutical form
LV
No
76
Element in interface
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Description
States the company and address. There may be
several companies per product. Swedish addresses
are given in Swedish format. Foreign addresses
are given in English format. For example,
Swedish addresses do not include SE- before the
postcode, and box numbers are stated as Box and
not P.O. Box. Foreign addresses are stated with
the postcode followed by the country code.
States the company's role, e.g. MAH or Agent.
Organisation's role can take values only from a
predefined list.
States the strength group that a product belongs to
if it is classified as interchangeable. Strength
group can take values only from a predefined list.
States the substance group that a product belongs
to if it is classified as interchangeable. Substance
group can take values only from a predefined list.
States the pharmaceutical form to which a product
belongs if it is classified as interchangeable. The
group name can take values only from a
predefined list.
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6 THE NPL WEBSITE
Screenshot 1 shows the homepage of NPL. This page is displayed when the website address is entered in the
Internet search engine used. The address of the NPL's homepage is: https://npl.mpa.se
Screenshot 1
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A. Review and verify product information.
This option is used to access products for review and verification. Products linked to companies either by an MAH
or an Agent are displayed. An e-mail address and password are used to log in. Users log in via option A.
B. User administration.
This option is used for the local administration of users at a company. The administrator assigned by the LIF
creates new administrators and users.
7 LOGGING IN AND THE PRODUCT REPORT
7.1 Logging in
You log into the NPL using your e-mail address and password. All logging in procedures work in the same way,
and are described in general terms in this chapter. After you have chosen one of the options A or B in Screenshot
1, the general logging in screen for the NPL (Screenshot 2) is displayed. You use your e-mail address for the user
name. You enter your password, which is assigned by the administrator, in the password box. You then log in
using the "Login" button. If you are authorised for several companies, these will be listed. Choose which
company's products you wish to review (Screenshot 3). To return to the first logging in window, click 'Log out'.
Screenshot 2.
Screenshot 3.
When you have logged in, a list of the company's products that you can review and verify is displayed.
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The list contains 10 products per page. The number of pages is shown below the list. The options below the list
allow you to display the "next" page or skip to the final page. You can also display the "previous" page or skip to
the first page. The company and your name (as the logged-in user from the company) are displayed at the top right
of the page. This is also where the log out (end session) option is. Logging out returns you to the NPL's
homepage.
A
Search criterion. State the status of products to be included in the search. Status is either 'verified' or
'not verified'. NOTE: you must always select at least one of these two to get hits on products.
B
Select withdrawn products here if you also want them to be included. The default is that withdrawn
products are not shown.
C
Select this box if you want to see only invalid products.
D
Search criterion. You can search for a specific product by entering all or the beginning of its name. You
can also search by entering a specific NPL ID. You can use % as a "wildcard", i.e. to replace unknown
letters. A new search term, Nordic item no. is also available. If you enter an item number, the hitlist
will display products for which a pack item number has been entered. Note that you can search only for
products linked to the logged-in company. Start the search by clicking "Search".
E
You can sort the list by clicking the column headings. You can obtain a product report by clicking a
product name (see Screenshot 4). "Last modified" shows when the LV and the LFN last updated the
product.
F
The withdrawal date for withdrawn products is shown here (if you searched using the withdrawn
products criterion).
G
States whether the product is valid (Y=Yes) or invalid (N=No).
The product information elements are displayed in different colours. Each principal is specified with its own
colour. The following nomenclature applies:
Blue = Medical Products Agency
Purple = Pharmaceutical Benefits Board
Brown = Company
Green = Apoteket AB
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7.2 The product report
Screenshot 4
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The numbers in Screenshot 4 correspond to the numbers in Table 1 that describe the elements to be
reviewed/verified.
A.
You can change the language of the product report by clicking the flags. Headings and some
information are changed to the language you select. Comments in free text are available only in
Swedish. Values selected from a predefined list, such as pharmaceutical forms, etc., are translated into
English.
B.
"Print Report" generates a preview of the paper printout and brings up the "Show audit" link. You print
the page generated on the screen using the printer button in your Internet browser's menu bar.
Click "Show audit" to see the traceability log, which is at the bottom of the product report. To return to
the previous screen, click 'Back'.
C.
"Changed" shows the date when the product information was last changed.
D.
If you have reviewed the information in the form, and it is correct, verify the information by clicking
"Yes, Set Verified". The status is then changed to verified. See Screenshot 3.
E.
If the information is not correct, click "No, Correct Errors". Screenshot 5 shows the form you use to
change information. This change form is displayed automatically when you click "No, Correct Errors".
F.
The lower part of the screenshot displays a status list for the products of the various parties who have
compiled the information.
G.
If you find information that you consider incorrect, and you are not authorised to change information in
accordance with E above and Screenshot 5, you can use the ”Send comment" option to send a request
for a change to the organisation that owns the incorrect information. When you click "Send comment",
a form already containing the e-mail address is displayed automatically. The sender is the logged-in
user (e-mail address). The e-mail form also includes information about the product to which the request
for a change applies. As a comment, you state the information you consider incorrect and what you
consider the correct information to be. Each organisation must then consider the requested change and
reply to the sender.
H.
The approval procedure is a new element in version 3 (see no. 14 in the Table).
I.
Displays the two product elements derived from the pack information (new in version 3). Companies
can no longer state Latex or Marketed for the product without it being stated on each pack.
J.
New field in version 3: "Previous item no.". This can be used to state the old item number when the
number has been changed on the pack.
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Screenshot 5
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Screenshot 5 shows the editing window where incorrect information can be corrected. It opens when you choose
the "No, correct errors" option. All values that can be changed in the interface are in brown italic. A grey row
highlight that tracks the cursor makes it easier to follow rows. The elements that can be changed are also shown in
Table 1.
The screenshot below shows how a parallel distributor (in this case Orifarm AB) looks during editing. A grey row
highlight that tracks the cursor makes it easier to follow rows. Boxes for entering information are available only
for that company's packs.
Note that information is saved in the repository only when you have left the editing window, i.e. when input boxes
are no longer visible and you have returned to the preview window.
7.3 Validation checks
Only packs that are being marketed are tested by the validation checks, i.e. the pack's "On the market" field = Yes.
Invalid packs have the value N=No in the "Valid" column in the hitlist. If a product is tested by the system as
"invalid", a red information symbol appears when you bring up the product report:
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If you click the "i" symbol it expands and shows an error message; to hide the message again, click "Hide" on the
far right.
Note that you cannot save changes for invalid products until you have corrected the errors.
For example, if a product has an incorrect item number on a pack, neither the LV nor the LFN can update the
product until the company has corrected the incorrect item number.
The following information is checked in the companies' fields:
 That there is a Nordic item number
 That the item number has six digits
 That there is an EAN code and that it consists of 8, 13 or 14 digits
 That the pack size is stated as quantity/unit
 That there is a quantity/unit if there is a multiple 1, and that there is a quantity/unit/multiple 1 if there is
a multiple 2.
 That there is a price
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 That there is an AIP (industry) and an AIP (LFN) and that they are the same.
 That there is no difference in the numeric strengths of the original and parallel-imported products
In addition, there are also some checks aimed at interchangeability and shelf life information, and comparisons
between original and parallel-imported products.
7.4 Warning messages
If a pack that is not on the market has an item number entered but no pack size is stated in "Size"/"Unit", a
warning appears when the product report is displayed. It is a warning that the NPL requires an indication of size
so that (e.g.) a price application can be dealt with by the LFN. It does not prevent product or pack information
being updated.
If you try to save an item number that already exist on a different pack following question will show:
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Review the list and answer the question in order to continue. The same item number exist on different packs if the
product is parallellimported from different countries. If a product appears on the list that should not have the same
item number that has to be corrected. Note that products from other companies will also appear on the list if they
incorrect have the same item number, if so contact ‘NPL Central’ or the fass.se support to forward a message to
the company.
7.5 Changes
NOTE: decimal numbers must be entered using the point (.) not the comma as the separator.
There are two different ways to add to or change existing information. You can either change free text or choose
an option from a predefined list. When a value for a particular element is missing, there is an "add" link to click
on to add the value.
Clicking the "add available date" option displays a field where you can add a new value for the date. An option for
removing the value is displayed at the same time.
When you have chosen the "add" option, an error message is displayed in the top part of the interface whatever the
information you are adding.
This is because a new element has been added to the document, and it has not yet been validated. When you have
saved the new value, the document is validated and the error message disappears.
Entering price has changed in version 3. When you want to add or change the price of a pack that is not
included in the benefits system, click "edit next price".
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State the next price (Next AIP) and the date on which the new price comes into force. To see retail prices, you
must first save the price and then click "Show AUP".
To remove a next price that has already been entered, click "Remove Next Price". See Chapter 8.2 for when prices
can be changed.
7.6 Error reporting
There is a separate instruction (available on the NPL website) for error reporting concerning accessibility,
functional faults, authorisation problems or content-related errors.
8 ONGOING CHANGES IN THE NPL
The quality assurance carried out by each company may involve different kinds of changes that must accordingly
be dealt with differently. Changes may be due on the one hand to simple mistakes, i.e. mistakes in the principal's
information system, and on the other to changed information that has not been notified to the principal concerned
and is therefore not included in their information system. It can be difficult to establish in every case the category
to which a mistake/change belongs.
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Certain information elements owned by the companies can be changed directly in the interface provided (see
Table 1).
Changes to other elements are noted by the company and sent via e-mail to the owning principal. An automatic email link with the address is available in the interface (see G, Screenshot 4). This link automatically includes some
information about the product in the e-mail. You add the information that you wish to change as free text, then
send the e-mail to the principal, who will make an assessment and reply to you. The company can then choose
either to delay verification until comments have been received from the principal or to verify immediately.
Previous procedures that involved sending a letter or fax to (e.g.) Apoteket AB are no longer operative.
Each product has one status flag per principal. The status can take the values "not verified", "verified" or
"changed". If the information about verified products is changed, the status is not automatically changed, whereas
the date changes to "last modified date". Companies can reset their flags to "changed" by clicking "No, set "Not
verified"" if they consider that they want to continue to review the information on another occasion.
A company's review is concluded when the statuses of all products are changed to verified.
To reduce the risk of information in the NPL having an incorrect format, products have been given an additional
status flag with the value valid or invalid. There are built-in validation checks that test products and set the status
values. If a product has the value valid=No, there is some mistake in the product information that must be
corrected. For example, the item number might have been entered with five digits when it should be six. NOTE:
no other changes can be made to information until the error has been corrected. The hitlist has a column giving the
product's validity status. See Chap. 9.1 for more information about validation checks.
8.1 New products
When a new product is approved for sale, the information is transferred to the NPL from the LVIS. Other
principals can subsequently supplement the information, and the company has the facility to review/verify the
product information by changing the status from "not verified" to "verified". The product information is available
externally for other parties immediately the company has changed the status from "not verified" to "verified".
New products transferred to the NPL will initially be unavailable to external users. The company has 30 days to
verify the product, after which the information becomes available externally but with the company's verification
flag set at "not verified", which warns that the information has not been reviewed by the company responsible. See
the NPL instruction "New product/new pack".
New extempore products are transferred to the NPL and reviewed by Apoteket AB.
When a new medicinal product is approved by the LV, it is published in the NPL and given current price
information from either the LFN or, if the product is outside the benefits scheme, from the company concerned.
For products that can be sold both OTC and on prescription within the benefit scheme, the company itself notes in
the NPL the AIP price that applies outside the benefits scheme. This must be the same AIP as that within the
benefits scheme because Apoteket does not deal with differentiated prices.
Apoteket AB will obtain all information from the NPL daily, then transfer it into Apoteket's internal systems for
article handling, sales, etc. Pharmacy sales of a new medicinal product, provided it is available, can begin the day
after the information is obtained from the NPL.
Because repository information is published internally in Apoteket AB's systems, it will also be published via
Apoteket's Internet service for updating the computerised prescribing systems used within healthcare. At a later
stage the healthcare service will be able to obtain information for updating prescribing systems directly from the
NPL.
8.2 Price changes
Apoteket AB will obtain new changed prices directly from the NPL for medicinal products within the
pharmaceutical benefits system as well as those outside the pharmaceutical benefits system. Companies need not
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notify new prices to Apoteket AB in any other way. Price changes for products within the pharmaceutical benefits
scheme are made to the LFN as previously.
Companies can change price information in the NPL up to 23:59 on the 5th of each month. The new price comes
into force at the pharmacy from the 1st of the following month. See Chapter 7.5 for changes in the NPL.
8.3 Withdrawal of products
After the company or the LV has notified about the expiry of the sales permit, the LVIS is updated with the expiry
date, and that date is transferred to the NPL. The company states that the product is not on the market and enters
“No” in the element “On the market”, see field 63 screenshot 4.
8.4 Other changes
Every principal is responsible for updating the NPL. The information is sent via Web services in accordance with
an established format.
A company making a change to product information that requires approval by the LV must first apply to the LV
before the change can be made in the NPL (variation). Following approval by the LV, the information is
transferred automatically from the LVIS to the NPL, where it is made available. The status of the product will not
be changed when there is an update with new information. If the product's status is "verified", the same status will
apply even after the LV has updated with the new information. The same applies after the transfer of information
from other principals. This can apply to changes such as
 discontinued medicinal products
 discontinued packs
 change of name
 change of form of medicinal product
 change to holder of sales permit
 changed Agent
Companies can change information they own, e.g. certain price information or the availability of packs on the
market, directly whenever they like via the interface.
Companies need not notify Apoteket of such changes in any other way. The information is sent to Apoteket only
via e-mail to Apoteket's mailbox: produktregistret@apoteket.se.
8.4.1 Change of item number
Companies themselves administer item numbers via the NPL, and Apoteket obtains new item numbers directly
from the NPL and replaces existing item numbers in Apoteket's terminal systems. The medicinal products companies
are responsible for changing item numbers at the appropriate time and for the changes being correct. Apoteket
does not check that the item numbers are correct. Each pack may have two item numbers, one current and one
historical.
8.4.2 Suspension of ordering
If a company wants to introduce information about the suspension of ordering for a product, this must be done via
the NPL. This information too is obtained by Apoteket directly from the NPL to be introduced into pharmacy
terminal systems. Information about the suspension of ordering has acquired increased importance due to the use
of a new monitoring system. Suspension of ordering should be used because this information carries less risk of
back orders at pharmacies. It also enables pharmacies to order available products more efficiently.
However, other procedures apply to immediate or emergency withdrawals linked to order and/or sale suspension.
(Red Web).
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8.4.3 Barcode (EAN code)
The barcode for packs you want to sell must always be stated in the NPL by entering the numeric code associated
with each barcode. Apoteket AB obtains the information from the NPL. This is very important information on the
medicinal product pack because it is used to confirm that the correct product is handed to the customer (picking
check) when Apoteket issues the product, and it is also the basis for payment.
8.5 Instructions
For further information about how to use the NPL register, see the instructions on the NPL's website. This has
descriptions of (e.g.) error reporting and a checklist for companies' reviews of new products/packs.
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