“SPECIALS”
LEGAL BACKGROUND &
INTRODUCTION TO GN14
Presented by Rob Lowe
Director of Quality Assurance Specialist
Services – East of England
THALIDOMIDE & THE MEDICINES ACT
“ I come to my last main topic which is the control and
safety of drugs. This is of course a subject which was
thrust to the fore both in this House and in the public press
a year or so ago as a result of the thalidomide tragedy. The
House and the public suddenly woke up to the fact that
any drug manufacturer could market any product, however
inadequately tested, however dangerous, without having to
satisfy any independent body as to its efficacy and safety
and the public was almost uniquely unprotected in this
respect.”
Kenneth Robinson, in a parliamentary debate on 8th May
1963
(Source; Hansard)
PRODUCT LICENSES OF RIGHT
1971 - 1991
39,000 PLR’s issued in May 1971 for all
medicinal products already on the UK market
 CRM (Committee on the Review of
Medicines) set up in 1975 to review all PLR’s
with a deadline of completion by 1990
 CRM review completed in 1991. Only 5,300
PLR licences had been renewed

THE MEDICINES ACT 1968

The Medicines Act is principally a licensing
act
 Introduced a comprehensive system of
licensing controlling the manufacture, sale,
supply & importation of medicines
 It became unlawful to engage in these
activities without the appropriate licence,
certificate or exemption.
 European law equivalent EC directive 65/65
THE MEDICINES AND HEALTHCARE
PRODUCTS REGULATORY AGENCY
(MHRA)

The Medicines Commission
 The British Pharmacopoeia Commission
 The Licensing Division
 The Post-licensing Division (Committee on
Safety of Medicines, Defective Medicines
Report Centre)
 Inspection & Enforcement Division
PRODUCT LICENCE APPLICATIONS

Clinical trial or bioavailability study data
 Toxicity information
 Manufacturing method
 Manufacturing site or contract manufacturer
 Container details
 Labelling and packaging details
 Patient Information Leaflet
 EC 65/65 “Marketing Authorisation” or MA
MANUFACTURERS LICENCE

Required to manufacture a PL medicine
 ML “specials” by product/activity type e.g.
small volume injectables, pre-packs etc.
Permits the holder to manufacture medicines
without a PL to Dr/Dentists order
 Inspected regularly by the MHRA to ensure
compliance with GMP standards including
raw material and finished product testing,
documentation, release procedures, training
and contamination control etc.
 Also required now for clinical trial material
SECTION 9 EXEMPTION

Doctors/Dentists do not need to have a PL for
any product prepared to their own
prescription for administration to a particular
patient.
 Nor do they require a ML for the above
though the manufacturer of the product may
require a ML “specials”
SECTION 11 EXEMPTION
A registered nurse or certified midwife does not
require a ML in order to assemble medicinal
products (i.e. reconstitute I.V.’s etc.) in the course
of his/her professional activities.
SECTION 10 EXEMPTION

A registered Pharmacist does not require a
ML to manufacture/prepare medicines in
accordance with a Dr’s prescription, or for
stock in anticipation of a prescription (limits
apply on quantity and frequency).
 A ML is not required to manufacture nonprescription medicines for sale in the course
of counter-prescribing.
 Preparation must be “by or under the
supervision of a Pharmacist”
SECTION 10 AND ASEPTICS

Preparation for stock should be avoided
 The preparation method uses closed systems
 Licensed medicinal products are used as
ingredients or ingredients are manufactured
in licensed facilities (i.e. are “specials”)
 Products have an expiry date of not more
than 1 week (supported by stability data)
 All activities are in accordance with defined
NHS guidelines (i.e. “Orange Guide”)
WHAT IS A “SPECIAL”

Medicines for Human Use (Marketing
Authorisations etc.) Regulations 1994 SI
no.3144 (Schedule 1 Exemptions)
 Exemption from the requirement for a MA
“a medicinal product to fulfil special needs,
supplied in response to a bona fide
unsolicited order, formulated in accordance
with the specification of a Dr or Dentist for
use by his/her patients on his/her direct
personal responsibility” Abridged
WHAT IS A “SPECIAL” 2
Is not “pharmaceutically equivalent” to a
licensed medicine
 Meets a “special need” of a patient e.g. liquid
if cant swallow tablets, preservative free eye
drops if allergic to preservative etc.
 If the licensed medicine becomes unavailable
then a “special” can be placed on the market
for as long as the licensed product is
unobtainable
 Convenience, safety of use or cost are not
justifications for manufacturing a “special”

PHARMACEUTICAL EQUIVALENCE

Contains the same amount of the same active
substance (same concentration if a liquid) AND
 Is in the same dosage form AND
 It meets the same or comparable standards
with regard to the clinical needs of the patient
at the time (e.g. purity/impurity)
“PLACING ON THE MARKET”

A product manufactured by 1 legal entity (e.g.
a Trust) and supplied to another is “placing on
the market”
 A product manufactured by a Trust for
administration to a patient within its premises
is not “placing on the market” BUT if supplied
to an out-patient who takes it off the Trust’s
premises this would be equivalent to “placing
on the market”
A “SPECIAL” IS NOT….

Investigational medicinal products
 A product prepared against a Dr’s
prescription (i.e. Section 10 exemption)
 “Off label” use of a licensed medicine
 Repackaged licensed products
 Reconstituted IV’s and CIVAS products
 Intermediate products
 Homeopathic and certain herbal remedies
PROCUREMENT & SUPPLY
Persons authorised to procure “specials”
include UK registered Dr’s/Dentists,
Pharmacists and licensed wholesalers who
supply the above.
 Supply must be for a bona fide unsolicited
order. As “specials” are not licensed it is
illegal to advertise them. This includes Price
Lists and Catalogues.
 A “specials” manufacturing service may be
advertised.

How to obtain a FREE copy of
GN14
Additional copies of GN14 are available from:
The MHRA Information Centre
Room 1207
Market Towers
THE SUPPLY OF UNLICENSED
RELEVANT MEDICINAL PRODUCTS
1 Nine Elms Lane
FOR INDIVIDUAL PATIENTS
London SW8 5NQ
phone 020 7084 2000
fax 020 7084 2353
www.mhra.gov.uk
MHRA Guidance Note No.14
Revised January 2008