PART 3 Manufacture and distribution of medicinal products and active substances
CHAPTER 2 Manufacturing and wholesale dealing
19.Exemptions from requirement for wholesale dealer's licence
21.Application for manufacturer's or wholesale dealer's licence
22.Factors relevant to determination of application for manufacturer's or wholesale dealer's licence
27.Procedure where licensing authority proposes to suspend, revoke or vary licence
45C.Procedure for determining an application for broker’s registration
45G.Power to suspend or vary a broker’s registration or remove a broker from the register
45H.Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register
45J.Variation of a broker’s registration on the application of the broker
CHAPTER 4 Importation, manufacture and distribution of active substances
45M.Criteria for importation, manufacture or distribution of active substances
45O.Requirements for registration as an importer, manufacturer or distributor of an active substance
45Q.Power to suspend or vary or remove an active substance registration
45R.Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register
45S.Suspension of an active substance registration in cases of urgency
45T.Variation of an active substance registration on an application from the registered person
PART 5 Marketing authorisations
Application for UK marketing authorisation
49.Application for grant of UK marketing authorisation or parallel import licence
52.Applications relating to certain medicinal products that do not qualify as generic etc
53.Applications relating to similar biological medicinal products
54.Applications relating to products in well-established medicinal use
55.Applications relating to new combinations of active substances
56.Applications containing information supplied in relation to another product with consent
57.Obligation to update information supplied in connection with application
57A.Obligation to update information supplied in connection with parallel import licence application
59.Conditions of UK marketing authorisation or parallel import licence: general
60.Conditions of UK marketing authorisation: exceptional circumstances
61.Conditions of UK marketing authorisation: new obligations post-authorisation
62.Classification of UK marketing authorisation or parallel import licence
64.Duties of licensing authority in connection with determination
Revocation, variation and suspension of marketing authorisation
Offences relating to EU marketing authorisations
81.Obligation to update information supplied in connection with EU application
82.EU marketing authorisations: failure to notify placing on market etc
83.EU marketing authorisations: failure to take account of technical and scientific progress
84.EU marketing authorisations: failure to provide information as to safety etc
85.EU marketing authorisations: failure to update product information
86.EU marketing authorisations: breach of pharmacovigilance condition etc
Offences relating to the safety features appearing on the packaging of medicinal products
PART 6 Certification of homoeopathic medicinal products
Application for certificate of registration and consideration of application
Revocation, variation and suspension of certificate of registration
PART 7 Traditional herbal registrations
Revocation, variation and suspension of traditional herbal registration
135.Revocation, variation and suspension of traditional herbal registration
138.Suspension of use etc of traditional herbal medicinal product
139.Registrations granted under Chapter 4 of Title III of the 2001 Directive
140.Withdrawal of traditional herbal medicinal product from the market
141.Sale etc of suspended traditional herbal medicinal product
PART 10 Exceptions to requirement for marketing authorisation etc
Obligations on licensing authority in relation to pharmacovigilance
Obligations on holders in relation to pharmacovigilance system
Recording, reporting and assessment of pharmacovigilance data
Periodic Safety Update Reports
191.Obligation on holder to submit periodic safety update reports: general requirements
191A.Obligation on holder of a parallel import licence to submit periodic safety update reports
192.Obligation on holder to submit periodic safety update reports: derogation from general requirements
194.Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
195.Obligation on licensing authority to assess PSURs where EU single assessment procedure does not apply
PART 12 Dealings with medicinal products
Exemptions relating to supply in specific circumstances
224.Emergency sale etc by pharmacist: prescriber unable to provide prescription
226A.Sale etc by a pharmacist in accordance with a serious shortage protocol
228.Exemptions relating to prescriptions given by certain health professionals
229.Exemption for supply by national health service bodies and local authorities
230.Exemption for supply etc under a PGD to assist doctors or dentists
231.Exemption for supply etc under a PGD by independent hospitals etc
232.Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
233.Exemption for supply etc under a PGD by person conducting a retail pharmacy business
234.Exemption for supply etc of products under a PGD to assist the police etc
235.Exemption for sale, supply or administration by certain persons
CHAPTER 4 Miscellaneous provisions, offences and disqualification
249.Restrictions on persons to be supplied with medicinal products
251.Compliance with standards specified in certain publications
252.Compliance with standards specified in certain publications: supplementary
254.Prohibitions concerning traceability of treatment with advanced therapy medicinal products
255A.Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public
255B.Exception to Article 25 of Commission Regulation 2016/161: health care institutions
255C.Offences relating to Commission Regulation 2016/161: management of the repository system
PART12A Sale of medicines to the public at a distance
256B.Person who may sell medicinal products by information society services
256C.Notification requirements for sellers of medicinal products at a distance
256D.Procedure for listing persons who may supply medicinal products at a distance
256F.Provision of information to the competent authority of a member State
256I.Power to suspend, vary or remove a person’s entry on the list
256J.Procedure where the competent authority of a member State proposes to suspend, vary or remove a person’s entry on the list
256K.Suspension of a person’s entry on the list in cases of urgency
256L.Variation of a person’s entry on the list on the application of that person
PART 13 Packaging and leaflets
Requirements for packaging and package leaflets relating to medicinal products
257A.Packaging Requirements: medicinal products required to bear safety features
259.Packaging requirements: information for blind and partially sighted patients
265.Additional requirements for traditional herbal medicinal products
267.Submission of mock-ups of packaging and leaflets to licensing authority
SCHEDULES
Supplementary provision relating to advisory bodies and expert advisory groups
Applications for licences under Part 3
Standard provisions of licences under Part 3
PART 1 Manufacturer's licence relating to manufacture and assembly
1.The provisions of this Part are standard provisions of a...
2.The licence holder must place the quality control system referred...
3.The licence holder may use a contract laboratory pursuant to...
4.The licence holder must provide such information as may be...
5.The licence holder must inform the licensing authority of any...
6.The licence holder must— (a) keep readily available for inspection...
7.The licence holder must keep readily available for examination by...
8.Where the licence holder has been informed by the licensing...
9.The licence holder must ensure that tests for determining conformity...
10.Where the manufacturer's licence relates to the assembly of a...
11.Where— (a) the manufacturer's licence relates to the assembly of...
12.The licence holder must keep readily available for examination by...
13.Where— (a) animals are used in the production of medicinal...
14.The licence holder must take all reasonable precautions and exercise...
15.The provisions of this Part are standard provisions of a...
16.The licence holder must place the quality control system referred...
17.The licence holder may use a contract laboratory pursuant to...
18.The licence holder must provide such information as may be...
19.The licence holder must— (a) keep readily available for inspection...
20.Where the licence holder has been informed by the licensing...
21.The licence holder must ensure that any tests for determining...
23.The licence holder must take all reasonable precautions and exercise...
PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products
PART 4 Wholesale dealer's licence
Wholesale dealer's licence relating to special medicinal products
32.The provisions of paragraphs 33 to 42 are incorporated as...
35.The licence holder may not import the special medicinal product...
36.The licence holder may import the special medicinal product referred...
37.Where the licence holder sells or supplies special medicinal products,...
38.The licence holder must not, on any one occasion, import...
39.The licence holder must inform the licensing authority immediately of...
40.The licence holder must not publish any advertisement, catalogue, or...
41.The licence holder must cease importing or supplying a special...
42.In this Part— “British approved name” means the name which...
Wholesale dealer's licence relating to exempt advanced therapy medicinal products
Review upon oral representations
Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
PART 1 Manufacturer's licences
2.The licence holder must inform the licensing authority of any...
3.The licence holder must ensure, if using human cells or...
4.The licence holder must ensure that any human tissue or...
6.Where the holder of a manufacturer's licence distributes by way...
8.The licence holder must establish and maintain a system ensuring...
9.The licence holder must, subject to paragraph 27 of Schedule...
10.The licence holder must secure that the data referred to...
11.The licence holder must, where an exempt advanced therapy medicinal...
12.The licence holder must not import or export any exempt...
PART 2 Wholesale dealer's licences
14.The licence holder must obtain supplies of exempt advanced therapy...
15.The licence holder must distribute an exempt advanced therapy medicinal...
16.The licence holder must establish and maintain a system ensuring...
17.The licence holder must inform the licensing authority of any...
18.The licence holder must, subject to paragraph 44 of Schedule...
19.The licence holder must secure that the data referred to...
20.The licence holder must not import or export any exempt...
PART 1 Qualification requirements for qualified person
1.A person must satisfy the requirements in paragraphs 2 and...
3.A qualification satisfies the requirements of this Part if it...
4.(1) A course should include at least the following core...
6.If two university courses, or courses recognised as of university...
7.If the person's formal qualifications do not satisfy the requirements...
8.(1) The person must (subject to sub-paragraph (2)) have at...
3.The address of each of the premises where any operations...
5.The address of each of the premises where active substances...
7.The name, address, qualifications and experience of the person whose...
8.The name, address, qualifications and experience of the person who...
9.The name, address, qualifications and experience of the person whose...
10.The name, address and qualifications of the person to be...
11.The name, address and qualifications of the person to be...
12.For each active substance to be manufactured, imported, or distributed—...
13.Details of the operations to which the registration relates, including...
14.A statement of the facilities and equipment available at each...
15.A statement as to whether the particular active substances are...
16.A separate statement in respect of each of the premises...
17.A statement of the authority conferred on the person responsible...
18.A description of the arrangements for the identification and storage...
19.A description of the arrangements for the identification and storage...
20.A description of the arrangements at each of the premises...
22.A description of the arrangements for keeping reference samples of—...
23.Where the application relates to active substances intended for use...
24.Details of— (a) any manufacturing, importation, storage or distribution operations,...
Material to accompany an application for a UK marketing authorisation
1.The name or corporate name and permanent address of the...
3.Qualitative and quantitative particulars of the constituents of the medicinal...
4.An evaluation of the potential environmental risks posed by the...
5.A description of the methods of manufacturing the medicinal product....
6.The therapeutic indications and contra-indications for the medicinal product and...
7.The posology and pharmaceutical form of the medicinal product, its...
8.The reasons for any precautionary and safety measures to be...
9.A description of the control methods employed by the manufacturer....
9A.A written confirmation that the manufacturer of the medicinal product...
10.The results of the following in relation to the medicinal...
11.A detailed summary of those results prepared and signed by...
12.A summary of the applicant's pharmacovigilance system which shall include...
14.Where any clinical trials have been carried out outside the...
15.A summary of the product characteristics for the medicinal product...
16.A mock-up, in accordance with Part 13 (packaging and leaflets)...
17.A document showing that the manufacturer of the medicinal product...
18.Where an application for authorisation for the medicinal product to...
19.Where an authorisation for the medicinal product to be placed...
20.Where an authorisation for the medicinal product to be placed...
21.Where an authorisation for the medicinal product to be placed...
Material to accompany an application for a parallel import licence
1.The name or corporate name and permanent address of the...
5.If requested by the licensing authority, an evaluation of the...
6.If requested by the licensing authority, a summary of the...
7.If requested by the licensing authority, the risk management plan,...
8.If requested by the licensing authority, a summary of the...
9.A mock-up, in accordance with Part 13 (packaging and leaflets)...
Undertakings by non-EEA manufacturers
1.The manufacturer must provide and maintain such staff, premises and...
2.The manufacturer must provide and maintain such staff, premises, equipment...
3.The manufacturer must provide and maintain a designated quality control...
4.The manufacturer must conduct all manufacture and assembly operations in...
5.The manufacturer must maintain an effective pharmaceutical quality assurance system...
6.Where animals are used in the production of any medicinal...
7.The manufacturer must make such adequate and suitable arrangements as...
8.The manufacturer must inform the holder of the marketing authorisation...
9.(1) The manufacturer shall keep readily available for inspection by...
10.The manufacturer must keep readily available for examination by a...
11.(1) The manufacturer must implement a system for recording and...
12.The manufacturer must inform the holder of the marketing authorisation...
National homoeopathic products
PART 3 Referral to the Committee for Herbal Medicinal Products
31.This Schedule does not apply to an application for the...
32.This Schedule does not apply to an application for the...
36.This Schedule does not apply if the application or proposal...
37.This Schedule does not apply if the application or proposal...
38.This Schedule does not apply if the application or proposal...
39.This Schedule does not apply if— (a) the licensing authority...
Material to accompany an application for a traditional herbal registration
1.The name or corporate name and permanent address of the...
3.Qualitative and quantitative particulars of the constituents of the medicinal...
4.An evaluation of the potential environmental risks posed by the...
5.A description of the methods of manufacturing the medicinal product....
6.The therapeutic indications and contra-indications for the medicinal product and...
7.The posology and pharmaceutical form of the medicinal product, its...
8.The reasons for any precautionary and safety measures to be...
9.A description of the control methods employed by the manufacturer....
10.Results of pre-clinical (toxicological and pharmacological) tests in relation to...
11.A detailed summary of those results prepared and signed by...
12.A summary of the product characteristics for the medicinal product...
13.A mock-up, in accordance with Part 13 (packaging and leaflets)...
14.A document showing that the manufacturer of the medicinal product...
15.Where the medicinal product consists of a combination of one...
16.Details of any authorisation or registration obtained by the applicant...
18.Bibliographical or expert evidence of the traditional use of the...
Prescription etc by supplementary prescribers: particulars of clinical management plan
PART 1 Particulars to be included in a patient group direction
1.The period during which the direction is to have effect....
2.The description or class of medicinal product to which the...
3.The clinical situations which medicinal products of that description or...
4.Whether there are any restrictions on the quantity of medicinal...
6.Whether any class of person is excluded from treatment under...
7.Whether there are circumstances in which further advice should be...
8.The pharmaceutical form or forms in which medicinal products of...
9.The strength, or maximum strength, at which medicinal products of...
13.Any minimum or maximum period of administration applicable to medicinal...
14.Whether there are any relevant warnings to note and, if...
PART 2 Persons on whose behalf a patient group Direction must be signed
Exemption for sale, supply or administration by certain persons
Medicinal products for parenteral administration in an emergency
Herbal medicinal products specified for the purposes of regulation 241
Medicinal products at high dilutions
PART 1 Dilutions of unit preparations diluted to at least one part in a thousand (3x)
PART 2 Dilutions of unit preparations diluted to at least one part in a million (6x)
PART 3 Dilutions of unit preparations diluted to at least one part in ten (1x)
PART 4 Dilutions of unit preparations diluted to at least one part in ten (1x) for external use
Packaging information requirements
PART 1 Outer and immediate packaging
3.Where appropriate, whether the product is intended for babies, children...
4.Where the product contains up to three active substances, the...
5.A statement of the active substances in the product, expressed...
6.The pharmaceutical form and the contents by weight, by volume...
8.The method of administration of the product and if necessary...
9.Where appropriate, space for the prescribed dose to be indicated....
12.The product's expiry date (month and year), in clear terms....
14.Any special precautions relating to the disposal of an unused...
16.The number of the marketing authorisation, Article 126a authorisation or...
Packaging requirements: specific provisions
Packaging requirements: special provisions
5.Where the product is to be administered to a particular...
8.Where the product is prescribed by an appropriate practitioner, such...
9.This paragraph applies if a pharmacist, in the exercise of...
10.Where paragraph 9 applies, the pharmacist may include such particulars,...
11.Where the product is not prescribed by an appropriate practitioner,...
3.Where appropriate, whether the product is intended for babies, children...
4.Where the product contains up to three active substances, the...
5.The pharmaco-therapeutic group, or type of activity, of the product,...
7.A list of— (a) contra-indications; (b) appropriate precautions for use;...
9.Instructions for proper use of the product including in particular—...
10.A description of the adverse reactions which may occur in...
11.A reference to the expiry date printed on the packaging...
12.Where the product is authorised under different names in different...
13.For medicinal products included in the list referred to in...
14.A standardised text relating to adverse event reporting in accordance...
15.The date on which the package leaflet was last revised....
Labelling requirements for registrable homoeopathic medicinal products
Particulars for advertisements to persons qualified to prescribe or supply
3.If the sample was purchased by the sampling officer otherwise...
4.If the sampling officer obtained the sample from a vending...
10.Unless the sampling officer decides not to submit the sample...
11.If a sample consists of substances or articles in unopened...
12.Regulation 343(1)(a) to (d) has effect in relation to supplying...
13.If after reasonable inquiry the sampling officer is unable to...
15.Where the enforcing authority that authorises the sampling officer is...
16.Where any other enforcing authority authorises the sampling officer, if...
17.(1) Arrangements of the kind mentioned in paragraphs 15(b) and...
18.A laboratory to which a sample is submitted under paragraph...
19.A laboratory that has analysed or examined a sample submitted...
Transitional arrangements: pharmacovigilance
2.Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (EC)...
4.Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...
6.The references to “the Eudravigilance database” in regulation 188(1)(a) and...
7.The licensing authority must ensure that all reports and updated...
8.Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...
10.The reference to “the EMA” in regulations 191(1) (obligation on...
PART 1 The Medicines Acts 1968 and 1971
2.For the text of section 1 (Ministers responsible for the...
3.In section 10 (exemptions for pharmacists)— (a) in subsection (1)...
4.In section 15 (provision for extending or modifying exemptions)—
6.In section 58A(1) (requirement to specify certain products as prescription-only...
7.In section 62 (prohibition of sale or supply, or importation,...
8.In section 64(5) (protection for purchasers of medicinal products) for...
10.In section 72 (representative of pharmacist in case of death...
11.In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...
13.In section 88(1) (distinctive colours, shapes and markings of medicinal...
14.In section 91 (offences under Part V, and supplementary provisions)—...
15.In section 104 (application of Act to certain articles and...
16.In section 105 (application of Act to certain other substances...
17.In section 107 (validity of decisions and proceedings relating thereto)—...
18.(1) Section 108 (enforcement in England and Wales) is amended...
19.In section 109 (enforcement in Scotland)— (a) in subsection (2)—...
21.In section 111 (rights of entry)— (a) in subsection (1)...
22.In section 113(1) (application of sampling procedure to substance or...
23.In section 114(1) (supplementary provisions as to rights of entry...
24.In section 121(4) (contravention due to default of other person),...
25.In section 122(2) (warranty as defence), for the words “section...
26.In section 123(1)(b) (offences in relation to warranties and certificates...
28.In section 126 (presumptions)— (a) in subsection (1), omit paragraph...
29.In section 128 (financial provisions)— (a) in subsection (1), for...
30.In section 129 (orders and regulations)— (a) in subsection (2),...
31.In section 130 (meaning of medicinal product and related expressions)—...
32.In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...
33.In section 132 (general interpretation provisions)— (a) for subsection (1)...
PART 4 The Medicines for Human Use (Clinical Trials) Regulations 2004
52.The Medicines for Human Use (Clinical Trials) Regulations 2004 are...
53.In regulation 2(1) (interpretation)— (a) before the definition “the Act”...
54.In regulation 4(3) (responsibility for functions under the Directive) for...
55.In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...
56.In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...
57.In regulation 47 (application of enforcement provisions of the Act)—...
58.In regulation 48(5) (infringement notices) for “sections 108 to 110...
59.In regulation 49(5) (offences) for “the Act” substitute “ the...
60.In regulation 53(3) (construction of references to specified publications) for...
61.In paragraph 4(2) of Schedule 5 (procedural provisions relating to...
62.In Schedule 7 (standard provisions for manufacturing authorisations)—
63.In paragraph 5(2) of Schedule 8 (procedural provisions relating to...
64.For Schedule 9 substitute the following Schedule— SCHEDULE 9 MODIFICATIONS OF...
PART 5 Other United Kingdom, Scotland and Wales Secondary legislation
Medicines (Administration of Radioactive Substances) Regulations 1978
Importation of Animal Products and Poultry Products Order 1980
Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986
Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
Medical Devices (Consultation Requirements) (Fees) Regulations 1995
General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999
National Health Service (Charges for Drugs and Appliances) Regulations 2000
Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001
Medicines for Human Use (Kava-kava) (Prohibition Order) 2002
Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003
Health Professions (Parts of and Entries in the Register) Order of Council 2003
National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
National Health Service (General Medical Services Contracts) Regulations 2004
National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
National Health Service (Personal Medical Services Agreements) Regulations 2004
General Optical Council (Registration Rules) Order of Council 2005
Human Tissue (Quality and Safety for Human Application) Regulations 2007
Legislative and Regulatory Reform (Regulatory Functions) Order 2007
Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
PART 6 Northern Ireland statutory rules
Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995
Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996
Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998
Importation of Animal Pathogens Order (Northern Ireland) 1999
Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003
Waste Management Licensing Regulations (Northern Ireland) 2003
Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006
Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007
Residential Family Centres Regulations (Northern Ireland) 2007
Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007
Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009