Application for a Manufacturer’s/Importer’s
Authorisation
Please refer to the ‘HPRA Guide to Applying for a Manufacturer’s/Importer’s
Authorisation’, available on www.hpra.ie.
Please note this application will be deemed invalid if the applicant is not ready for
inspection at the time of submission of this application.
1.
APPLICANT DETAILS (Relating to Schedule 1)
Authorisation number (provided on receipt of
application)
Name of authorisation holder
Address(es) of manufacturing site(s):
(Please list all addresses where
manufacturing/importation operations will take place
under this proposed manufacturer’s authorisation.)
Legally registered name of proposed authorisation
holder
Legally registered address of proposed authorisation
holder
Companies Registration Office Number:
(Please include certificate of incorporation with
application.)
Business name (trading as) (if applicable)
Companies Registration Office Number for business
name
(Please also include Certificate of Registration relating
to the trading style from the Companies Registration
Office)
Name and address of applicant (if different from the
proposed authorisation holder)
Contact telephone number
Contact fax number
Email address of applicant
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2.
TYPE OF AUTHORISATION REQUESTED
Manufacturer’s authorisation for medicinal products for human use
Manufacturer’s authorisation for investigational medicinal products for human use
Manufacturer’s authorisation for medicinal products for veterinary use
Note: separate applications are required for each type of authorisation identified above.
3.
SCOPE OF AUTHORISATION/LICENCE (delete the sections that do not apply)
The information in this section of the form is relevant to Annex 1 or Annex 2 and will be
designated in the final authorisation document depending on the type of authorisation selected
in the previous step.
Name and address of the site:
Manufacturing operations (according to part 1)
Importation of medicinal products (according to part 2)
Part 1 Manufacturing operations
Note: where a category is selected which includes a provision for <free text> then enter the
relevant descriptive text in the <free text> box.
1.1
Sterile Products
1.1.1
Aseptically prepared (processing operations for the following dosage forms)
1.1.1.1
1.1.1.2
1.1.1.3
1.1.1.4
1.1.1.5
1.1.1.6
Large volume liquids
Lyophilisates
Semi-solids
Small volume liquids
Solids and implants
Other aseptically prepared products <free text>
1.1.2
Terminally sterilised (processing operations for the following dosage forms)
1.1.2.1
1.1.2.2
1.1.2.3
1.1.2.4
1.1.2.5
Large volume liquids
Semi-solids
Small volume liquids
Solids and implants
Other terminally sterilised prepared products <free text>
1.1.3
Batch certification
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1.2
Non-sterile products
1.2.1
Non-sterile products (processing operations for the following dosage forms)
1.2.1.1
1.2.1.2
1.2.1.3
1.2.1.4
1.2.1.5
1.2.1.6
1.2.1.7
1.2.1.8
1.2.1.9
1.2.1.10
1.2.1.11
1.2.1.12
1.2.1.13
1.2.1.14
1.2.1.15
1.2.1.16
1.2.1.17
Capsules, hard shell
Capsules, soft shell
Chewing gums
Impregnated matrices
Liquids for external use
Liquids for internal use
Medicinal gases
Other solid dosage forms
Pressurised preparations
Radionuclide generators
Semi-solids
Suppositories
Tablets
Transdermal patches
Intraruminal devices
Veterinary premixes
Other non-sterile medicinal product <free text>
1.2.2
Batch certification
1.3
Biological medicinal products
1.3.1
Biological Medicinal Products (list of product types)
1.3.1.1
1.3.1.2.
1.3.1.3
1.3.1.4
1.3.1.5
1.3.1.6
1.3.1.7
1.3.1.8
Blood products
Immunological products
Cell therapy products
Gene therapy products
Biotechnology products
Human or animal extracted products
Tissue engineered products
Other biological medicinal products <free text>
1.3.2 Batch certification (list of product types)
1.3.2.1
Blood products
1.3.2.2
Immunological products
1.3.2.3
Cell therapy products
1.3.2.4
Gene therapy products
1.3.2.5
Biotechnology products
1.3.2.6
Human or animal extracted products
1.3.2.7
Tissue engineered products
1.3.2.8
Other biological medicinal products <free text>
1.4
Other products or manufacturing activity
1.4.1
Manufacture of:
1.4.1.1
1.4.1.2
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Herbal products
Homoeopathic products
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1.4.1.3
1.4.2
Other <free text>
Sterilisation of active substances/excipients/finished product
1.4.2.1
1.4.2.2
1.4.2.3
1.4.2.4
1.4.2.5
1.4.2.6
Filtration
Dry heat
Moist heat
Chemical
Gamma irradiation
Electron beam
1.4.3
Other <free text>
1.5
Packaging
1.5.1
Primary packing
1.5.1.1
1.5.1.2
1.5.1.3
1.5.1.4
1.5.1.5
1.5.1.6
1.5.1.7
1.5.1.8
1.5.1.9
1.5.1.10
1.5.1.11
1.5.1.12
1.5.1.13
1.5.1.14
1.5.1.15
1.5.1.16
1.5.1.17
Capsules, hard shell
Capsules, soft shell
Chewing gums
Impregnated matrices
Liquids for external use
Liquids for internal use
Medicinal gases
Other solid dosage forms
Pressurised preparations
Radionuclide generators
Semi-solids
Suppositories
Tablets
Transdermal patches
Intraruminal devices
Veterinary premixes
Other non-sterile medicinal products <free text>
1.5.2
Secondary packing
1.6
Quality control testing
1.6.1
1.6.2
1.6.3
1.6.4
Microbiological: sterility
Microbiological: non-sterility
Chemical/Physical
Biological
Any restrictions or clarifying remarks related to the scope of these manufacturing
operations
<free text>
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Part 2 Importation of medicinal products
2.1
Quality control testing of imported medicinal products
2.1.1
2.1.2
2.1.3
2.1.4
2.2
Microbiological: sterility
Microbiological: non-sterility
Chemical/Physical
Biological
Batch certification of imported medicinal products
2.2.1
Sterile Products
2.2.1.1
2.2.1.2
Aseptically prepared
Terminally sterilised
2.2.2
Non-sterile products
2.2.3
Biological medicinal products
2.2.3.1
2.2.3.2
2.2.3.3
2.2.3.4
2.2.3.5
2.2.3.6
2.2.3.7
2.2.3.8
2.3
Blood products
Immunological products
Cell therapy products
Gene therapy products
Biotechnology products
Human or animal extracted products
Tissue engineered products
Other biological medicinal products <free text>
Other importation activities (any other relevant importation activity not covered above)
2.3.1
2.3.2
2.3.3
2.3.4
Site of physical importation
Importation of intermediate which undergoes further processing
Biological Active Substance
Other <free text>
Any restrictions or clarifying remarks related to the scope of these importation operations
<free text>
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ANNEX 3 CONTRACT MANUFACTURER(S)
Please complete a separate Annex 3 for each contract manufacturer.
Name and address of the contract manufacturing site:
Located within the EEA: Yes
No
(if no add details relating to each medicinal product
imported from outside the EEA in Annex 8).
Authorisation Number (for sites located in the EEA):
Date of last EEA inspection:
Please check the relevant items and delete any checkbox items below which are not applicable.
1.1
Sterile Products
1.1.1
Aseptically prepared (processing operations for the following dosage forms)
1.1.1.1
1.1.1.2
1.1.1.3
1.1.1.4
1.1.1.5
1.1.1.6
1.1.2
Large volume liquids
Lyophilisates
Semi-solids
Small volume liquids
Solids and implants
Other aseptically prepared products <free text>
Terminally sterilised (processing operations for the following dosage forms)
1.1.2.1
1.1.2.2
1.1.2.3
1.1.2.4
1.1.2.5
Large volume liquids
Semi-solids
Small volume liquids
Solids and implants
Other terminally sterilised prepared products <free text>
1.2
Non-sterile products
1.2.1
Non-sterile products (processing operations for the following dosage forms)
1.2.1.1
1.2.1.2
1.2.1.3
1.2.1.4
1.2.1.5
1.2.1.6
1.2.1.7
1.2.1.8
1.2.1.9
1.2.1.10
1.2.1.11
1.2.1.12
1.2.1.13
1.2.1.14
1.2.1.15
AUT-F0200-10
Capsules, hard shell
Capsules, soft shell
Chewing gums
Impregnated matrices
Liquids for external use
Liquids for internal use
Medicinal gases
Other solid dosage forms
Pressurised preparations
Radionuclide generators
Semi-solids
Suppositories
Tablets
Transdermal patches
Intraruminal devices
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1.2.1.16
1.2.1.17
Veterinary premixes
Other non-sterile medicinal product <free text>
1.3
Biological medicinal products
1.3.1
Biological Medicinal Products (list of product types)
1.3.1.1
1.3.1.2.
1.3.1.3
1.3.1.4
1.3.1.5
1.3.1.6
1.3.1.7
1.3.1.8
Blood products
Immunological products
Cell therapy products
Gene therapy products
Biotechnology products
Human or animal extracted products
Tissue engineered products
Other biological medicinal products <free text>
1.4
Other products or manufacturing activity
1.4.1
Manufacture of:
1.4.1.1
1.4.1.2
1.4.1.3
1.4.2
Herbal products
Homoeopathic products
Other <free text>
Sterilisation of active substances/excipients/finished product
1.4.2.1
1.4.2.2
1.4.2.3
1.4.2.4
1.4.2.5
1.4.2.6
Filtration
Dry heat
Moist heat
Chemical
Gamma irradiation
Electron beam
1.4.3
Other <free text>
1.5
Packaging
1.5.1
Primary packing
1.5.1.1
1.5.1.2
1.5.1.3
1.5.1.4
1.5.1.5
1.5.1.6
1.5.1.7
1.5.1.8
1.5.1.9
1.5.1.10
1.5.1.11
1.5.1.12
1.5.1.13
1.5.1.14
1.5.1.15
1.5.1.16
1.5.1.17
AUT-F0200-10
Capsules, hard shell
Capsules, soft shell
Chewing gums
Impregnated matrices
Liquids for external use
Liquids for internal use
Medicinal gases
Other solid dosage forms
Pressurised preparations
Radionuclide generators
Semi-solids
Suppositories
Tablets
Transdermal patches
Intraruminal devices
Veterinary premixes
Other non-sterile medicinal products <free text>
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1.5.2
1.6
Secondary packing
Quality control testing
1.6.1
1.6.2
1.6.3
1.6.4
AUT-F0200-10
Microbiological: sterility
Microbiological: non-sterility
Chemical/Physical
Biological
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ANNEX 4 CONTRACT LABORATORY
Please complete a separate Annex 4 for each contract laboratory.
Name of contract laboratory:
Address of contract laboratory:
Tick relevant testing operations below:
Microbiological: sterility
Microbiological: non sterility
Chemical/physical
Biological
Stability testing (This is applicable only where all testing operations carried out at the contract
laboratory relate to stability testing only. If the contract laboratory carries out multiple testing
operations and only some of these apply to stability testing, then this is not applicable.)
Located within the EEA: Yes
No
Authorisation number (where applicable):
Date of last EEA inspection:
site)
(as per date referenced on last GMP certificate issued for the
Where the laboratory will only be used for testing in relation to IMPs or stability testing of
medicinal products, submit a declaration of GMP compliance from a QP named on the
authorisation. The HPRA reserves the right to perform its own inspection if deemed necessary or
to request another relevant authority to inspect where appropriate.
Evidence of satisfactory inspection by an MRA authority:
For contract laboratories located in an MRA territory, please provide evidence of a satisfactory
outcome to any inspection which has taken place within the last three years and is relevant to
the activities which are (or will be) carried out at the site.
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ANNEX 5 QUALIFIED PERSON(S)
Please submit a curriculum vitae, copy of QP Qualification and training records for the following
personnel:
-
Qualified person(s) (please specify primary or deputy, if applicable)
Title
First name
Last name
Qualifications
Additional information
ANNEX 6 PERSONNEL FOR PRODUCTION OPERATIONS AND QUALITY CONTROL
Please provide a Curriculum Vitae and training records for the following personnel:
-
Person(s) responsible for production operations
-
Person(s) responsible for quality control
Name(s) of production personnel
Title
First name
Last name
Qualifications
Additional information
Qualifications
Additional information
Name(s) of quality control personnel
Title
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First name
Last name
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ANNEX 7 (OPTIONAL) – NOT USED BY THE HPRA
If completed, this information will not appear on the authorisation.
Date of inspection following which authorisation was granted: <dd/mm/yyyy>
Scope of last inspection:
ANNEX 8 IMPORTATION OF PRODUCTS WHICH ARE CONTRACT MANUFACTURED AT A
SITE OUTSIDE THE EEA
Enter the name and address below of the contract manufacturer as already completed in Annex 3.
Name and address of the contract manufacturing site:
Product type:
Product description
Dosage form:
Details of imported product
Strength
Active ingredient
Activities by MIA holder
Batch certification Site of physical
importation
Please add rows as necessary to the table above to cover all relevant products manufactured at
this site.
Please complete a separate Annex 8 for each relevant manufacturer.
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OTHER REQUIREMENTS FOR APPLICATIONS FOR A MANUFACTURER’S/IMPORTER’S
AUTHORISATION
Recall procedure
Please submit a copy of the company’s recall procedure.
Explanatory notes on the preparation of a recall procedure can be found on www.hpra.ie.
Site master file
Please submit a copy of the facility’s site master file.
Explanatory notes on the preparation of a site master file can be found on www.picscheme.org.
Other authorisations/licences held
(Relevant only to other authorisations/licences granted by the HPRA)
Name and address of authorised/licensed establishment:
Authorisation/licence number:
Fees/classification of facility
Please submit an application fee with each request for a manufacturer’s authorisation. An annual
maintenance fee is also payable in respect of each authorisation and is related to the size of the
facility based on the numbers of relevant employees.
(Tick as appropriate)
A major site (>250 employees)
A large site (150-250 employees)
A medium site (50-149 employees)
A small site (<50 employees)
Please refer to the Guide to Fees for Human Products/Guide to Fees for Veterinary Products on
www.hpra.ie and complete the appropriate fee application form.
Declaration
In the event of the authorisation being granted, I undertake to ensure fulfilment of the
obligations arising by virtue of the terms and conditions of the authorisation and declare that
the above particulars are, to the best of my knowledge and belief, correct.
Signature:
Date:
Print name:
Title/position:
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CHECKLIST OF DOCUMENTS
The following information must be submitted with the application (except where not applicable).
Please tick the checkboxes below to confirm the documents have been included with the
application.
Letter of application
Certificate of incorporation
Details (name, address and operation) of contract manufacturing sites
Details (name, address and operation) of contract laboratories
List of products (including name of API, dosage form and strength) imported from
outside the EEA
Details relating to proposed Qualified Person(s)
Details relating to proposed Person(s) responsible for Quality Control
Details relating to proposed Person(s) responsible for Production Operations
Recall procedure
Site master file
Classification of facility size
Fee application form
Relevant fee
Signed declaration
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