The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

• (3) The requirement of sub-paragraph (1)(c) shall apply to every container and every package immediately enclosing a container of a relevant medicinal product which is sold by way of wholesale dealing and which is not a relevant medicinal product on a general sale list.

• (4) Where a container or package is required by this paragraph to be labelled to show any of the words or particulars specified in heads (a) to (e) of sub-paragraph (2), such words or particulars shall be within a rectangle within which there shall be no other matter of any kind, except that where words or particulars set out in more than one head of that sub-paragraph appear on the container or package then any of them may be together within a rectangle within which there shall be no other matter of any kind.

Prescription only relevant medicinal products

7

Subject to the following provisions of this Schedule, every container and every package immediately enclosing a container of a relevant medicinal product which is subject to restrictions imposed under section 58(1) of the Act (relevant medicinal products on prescription only) shall, if the product is described in heads (d) or (e) of sub-paragraph (2) of paragraph 6, be labelled to show the words and particulars set out in that head and shall, except where the product is sold by retail or supplied in circumstances corresponding to retail sale or is the subject of an exemption, by virtue of the provisions of section 58(4)(a), from any of the restrictions imposed by section 58(2) of the Act, be labelled to show the letters “POM” in capital letters within a rectangle within which there shall be no other matter of any kind.

Exemptions

8

Nothing in this Schedule shall require the labelling of—

• (a) any package in the form of a transparent wrapping or cover to a container and package of a relevant medicinal product or any package the whole or part of which is transparent or open if the particulars shown on the labelled container enclosed in that package are clearly visible;

• (b) any package in the form of a wrapping paper, paper bag or similar covering in which the container and package of a relevant medicinal product labelled in accordance with the provisions of this Schedule is placed when such relevant medicinal product is sold by retail or supplied in circumstances corresponding to retail sale; or

• (c) any container or package immediately enclosing the container of a relevant medicinal product which is for export;

• (d) any container which is—

• (i) an ampoule or other container of not more than 10 millilitres nominal capacity which is immediately enclosed in a package which is labelled in accordance with those provisions of paragraphs 5 to 7 which apply to such package;

• (ii) in the form of a wrapper consisting of paper, film, plastic material, metal foil or other sheet or strip material or in the form of a bubble, blister or other sealed unit consisting of such sheet or strip material, enclosing one or more dosage units of a relevant medicinal product and such container is immediately enclosed in a package which is labelled in accordance with those provisions of paragraphs 5 to 7 which apply to such package;

• (iii) where the package immediately enclosing such a container as is described in head (ii) above is itself in the form of a bubble, blister or other sealed unit as is mentioned in that head and is part of a continuous series comprising a sheet or strip of like packages and is required to be labelled to show any of the words, particulars or letters referred to in paragraphs 5 to 7, such requirements shall be deemed to have been complied with if the said words, particulars or letters, as the case may be, are displayed at frequent intervals on the said sheet or strip of such packages.

SCHEDULE 6 — TRANSITIONAL PROVISIONS

1

If on 1st January 1995 there is in force in relation to a medicinal product for human use to which these Regulations apply a product licence granted under Part II of the Act, that product licence shall have effect from that date as if it were a marketing authorization granted under these Regulations.

2

Accordingly any right conferred or obligation imposed by these Regulations shall be conferred or imposed on the holder of such a product licence, except that the provisions of regulation 7(6) (which requires the holder of a marketing authorization to be established in the Community) and the provisions of Schedule 5 (labels) shall not apply.

3

• (1) Subject to sub-paragraph (2), any application for a product licence made before the date when these Regulations come into force but not then determined shall from that date be treated as an application for a marketing authorization, and the provisions of Schedule 2 shall apply accordingly.

• (2) Where any act has been done in relation to an application to which sub-paragraph (1) applies before the date when these Regulations come into force, nothing in that sub-paragraph requires that act to be repeated.

4

The provisions of the Medicines (Labelling) Regulations 1976[^f00028] and of the Medicines (Leaflets) Regulations 1977[^f00029] (and subsequent regulations amending those Regulations) in so far as they relate to relevant medicinal products shall continue to have effect in relation to any relevant medicinal product in respect of which there is in force on the date these Regulations come into force a product licence under Part II of the Act, until the date when that licence is renewed.

5

Until 31st March 1995 the Medicines (Products for Human Use—Fees) Regulations 1991[^f00030] shall have effect as if—

• (a) any reference to a product licence or to licences under Part II of the Act included a reference to a United Kingdom marketing authorization;

• (b) in regulation 2(1), the definition of “medicinal product” included a reference to a relevant medicinal product;

• (c) in regulation 7, the reference to an application under section 30 of the Act to vary a product licence included a reference to an application under regulation 4 above to vary a United Kingdom marketing authorization; and

• (d) in head 1(a)(i) in Column 1 of the Table in Part II of Schedule 1, paragraphs 2 and 2A of Part III of that Schedule and in the definition of “limited use drug” in paragraph 1 of Part I of Schedule 3, the references to paragraph 5 of Schedule 2 to the Applications Regulations included references to section G of Part 4 of the Annex to Council Directive 75/318/EEC[^f00031].

SCHEDULE 7 — CONSEQUENTIAL AMENDMENTS TO REGULATIONS

1

In the Medicines (Exemption from Licences) (Wholesale Dealing in Confectionery) Order 1975[^f00032] after paragraph (2) of regulation 1 there shall be inserted the following paragraph—

(2A) In this Order a reference to a medicinal product includes a reference to a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994, and a reference to a product licence includes a reference to a marketing authorization within the meaning of those Regulations.

2

In the Medicines (Child Safety) Regulations 1975[^f00033] in sub-paragraph (d) of paragraph (3) of regulation 2, after the words “by virtue of the relevant product licence” there shall be inserted the words “or marketing authorization (within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994)”.

3

In the Medicines (Labelling) Regulations 1976[^f00034]—

• (a) for the heading to regulation 1 there shall be substituted the heading “Citation and scope”;

• (b) regulation 1 shall be re-numbered paragraph (1) of regulation 1; and

• (c) after that paragraph there shall be inserted the following paragraph—

(2) Nothing in these Regulations applies to a medicinal product for human use to which the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 apply.

4

In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977[^f00035] for paragraph (1) of regulation 2 there shall be substituted the following paragraph—

(1) In these Regulations, unless the context otherwise requires— (a) “medicinal product” includes a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and, where a product licence relates to any substance or article which is not a medicinal product, the substance or article to which the licence relates or is intended to relate; (b) “product licence” includes a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994; and (c) other expressions have the same meanings as in the Medicines Act 1968.

5

In the Medicines (Leaflets) Regulations 1977[^f00036]

• (a) for the heading to regulation 1 there shall be substituted the heading “Citation, commencement and scope”;

• (b) regulation 1 shall be re-numbered paragraph (1) of regulation 1; and

• (c) after that paragraph there shall be inserted the following paragraph—

(2) Nothing in these Regulations applies to a medicinal product for human use to which the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 apply.

6

In the medicines (Fluted Bottles) Regulations 1978[^f00037], in paragraph (g) of regulation 3, after the words “product licence,” there shall be inserted the words “a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994,”.

7

In the Importation of Animal Products and Poultry Products Order 1980[^f00038], after the words “or the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994” there shall be inserted the words “or the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

8

In the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980[^f00039], in sub-paragraph (a) of paragraph (1) of regulation 5, after the words “product licence” there shall be inserted the words “or the holder of a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

9

In the Medicines (Pharmacy and General Sale) Exemption Order 1980[^f00040]—

• (a) in paragraph 11 of Column 1 of Schedule 1, after the words “Holders of product licences” there shall be inserted the words, “holders of marketing authorizations within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”; and

• (b) in paragraph 11 of Column 2 of that Schedule, at the end there shall be added the words “or marketing authorizations”.

10

In the Health and Safety (Dangerous Pathogens) Regulations 1981[^f00041], in regulation 2(1) in the definition of “listed pathogen”, after the words “marketing authorisation to which the Marketing Authorisations for Veterinary Medicinal Products Regulations 1984” there shall be inserted the words “or the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

11

In the Food Labelling Regulations 1984[^f00042], in Column 2 of paragraph 7, at the end there shall be added the words “or a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

12

In the Natural Mineral Waters Regulations 1985[^f00043], in sub-paragraph (c) of paragraph (1) of regulation 3, at the end there shall be added the words “or a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

13

In the Merchant Shipping (Medical Stores) Regulations 1986[^f00044], in sub-paragraph (d) of paragraph (3) of regulation 6, after the words “product licence” there shall be inserted the words “or marketing authorization”.

14

In the Trade Descriptions (Places of Production) (Marking) Order 1988[^f00045], in article 1(2)(d) after the words “Marketing Authorisations for Veterinary Medicinal Products Regulations 1994” there shall be inserted the words “or the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

15

In the Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990[^f00046]—

• (a) in paragraph (2) of regulation 1, after the definition of “intermediate feed” there shall be inserted the following definition—

• “marketing authorization” has the same meaning as in the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994;

• (b) in the definition of “medicinal product” in that paragraph, after head (c) there shall be inserted—

(d) relevant medicinal products within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994;

• (c) in paragraph (1) of regulation 2—

• (i) in sub-paragraph (a), after the words “product licence” (in both places where they occur) there shall be inserted the words “or marketing authorization”; and

• (ii) in sub-paragraph (b), after the words “product licence” (in both places where they occur) there shall be inserted the words “or marketing authorization”.

16

In the Children’s Homes Regulations 1991[^f00047], in paragraph (1) of regulation 2, in the definition of “medicinal product”, after the words “Medicines Act 1968” there shall be inserted the words “or a marketing authorization under Council Regulation (EEC) No. 2309/93 or the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

17

In the Medicines (Applications for Grant of Product Licences-Products for Human Use) Regulations 1993[^f00048], after paragraph (1) of regulation 1 there shall be inserted the following paragraph—

(1A) Nothing in these Regulations applies to a medicinal product for human use to which the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 apply.

18

In the Specified Animal Pathogens Order 1993[^f00049], in sub-paragraph (a) of paragraph (2) of regulation 5, after the words “the Medicines Act 1968” there shall be inserted the words “or a marketing authorization has been granted under Council Regulation (EEC) No. 2309/93 or the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

19

In the Drinking Water in Containers Regulations 1994[^f00050], in paragraph (b) of regulation 3, after the words “product licence within the meaning of that Act” there shall be inserted the words “or a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

20

In the Medicines (Advertising) Regulations 1994[^f00051]—

• (a) in paragraph (1) of regulation 2, after the definition of “essential information” there shall be inserted the following definition—

• “marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or by the licensing authority under the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and includes a product licence granted by the licensing authority under Part II of the Act;

• (b) in paragraph (1) of regulation 3, for the words “product licence” there shall be substituted the words “marketing authorization”; and

• (c) in regulation 4 for the words “product licence” there shall be substituted the words “marketing authorization”;

• (d) type=end time=1574846007474in sub-paragraph (l)type=start time=1574846144519 of paragraph (1) of regulation 9, for the words “product licence” there shall be substituted the words “marketing authorization”;

• (e) in regulation 12, for the words “product licence” there shall be substituted the words “marketing authorization”; and

• (f) in Schedule 2—

• (i) in paragraph 1, for the word “licence” there shall be substituted the word “authorization”;

• (ii) in paragraph 2, for the words “product licence” there shall be substituted the words “marketing authorization”; and

• (iii) in paragraph 5, for the word “licence” there shall be substituted the word “authorization”; and

21

In the General Product Safety Regulations 1994[^f00052], in regulation 11(c)(ii)(aa), after the words “the provisions of the 1968 Act” there shall be inserted the words “or which are the subject of a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

• (b) regulation 1 shall be re-numbered paragraph (1) of regulation 1; and

• (c) after that paragraph there shall be inserted the following paragraph—

(2) Nothing in these Regulations applies to a medicinal product for human use to which the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 apply.

22

In the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994(b), in regulation 3(1)(b), after the words “a medicinal product licensed” there shall be inserted the words “or authorized in accordance with the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994”.

Signed

Signed by authority of the Secretary of State for Health

Tom Sackville — Parliamentary Under Secretary of State, — Department of Health — 8th December 1994

Explanatory note

(This note is not part of the Regulations)

These Regulations implement for the United Kingdom, and in so far as they are concerned with medicinal products for human use, the Council Directives mentioned in regulation 1(2) in the definition of “relevant Community provisions”. They also contain provisions supplementing the provisions of Council Regulation (EEC) No. 2309/93. Both the Directives and the Regulation are concerned with the marketing of medicinal products.

The Regulations provide that the functions of a member state or the competent authority of a member State under the relevant Community provisions are, except as otherwise provided, to be performed in the United Kingdom by the licensing authority (ie the Ministers in the United Kingdom concerned with health and agriculture— see sections 1 and 6 of the Medicines Act 1968) (regulation 2). They also provide that no medicinal product for human use which is subject to the relevant Community provisions may be placed on the market in the United Kingdom or be dealt with by way of wholesale dealing unless there is in force in respect of it a marketing authorization granted either by the European Commission or by the licensing authority (regulation 3).

Regulations 4 to 7 and Schedules 2 and 3 provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization, the procedure for the consideration of such an application, the revocation and suspension of a marketing authorization and the suspension of the use or marketing of medicinal products and the obligations of applicants for and holders of marketing authorizations. In particular regulation 7(4) and Schedule 3 create certain offences in connection with those obligations.

Regulation 8 is about the control of retail sale or supply of relevant medicinal products. Regulation 9 makes consequential and other amendments to the Medicines Acts 1968 and 1971.

Schedule 1 makes certain exceptions and exemptions from the requirement to hold a marketing authorization. Schedule 4 contains provisions applying with modifications the provisions of the Medicines Act 1968 about enforcement. Schedule 5 contains provisions about the labelling of medicinal products, Schedule 6 contains transitional provisions and Schedule 7 makes consequential amendments to other regulations.

An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Footnotes

[^f00001]: 1972 c. 68.

[^f00002]: See The European Communities (Designation) Order 1972 (S.I. 1972/1811).

[^f00003]: OJ No. L214, 24.8.93, p.1.

[^f00004]: OJ No. L214, 24.8.93, p.22.

[^f00005]: S.I. 1994/.

[^f00006]: 1968 c. 67. Relevant amendments were made by the Prescription by Nurses Act 1992 (c. 28), section 1 and S.I. 1977/1050, 1983/1724, 1992/604, 605 and 3271 and 1993/834.

[^f00007]: OJ No. L214, 24.8.93, p.1.

[^f00008]: OJ No. L22, 9.2.65, p.369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p.1); 87/21/EEC, (OJ No. L15, 17.1.87, p.36), 89/343/EEC (OJ No. L142, 25.5.89, p.16) and 93/39/EEC (OJ No. L214, 24.8.93, p.22.).

[^f00009]: OJ No. L147, 9.6.75, p.1. The Directive was amended by Directives 89/341/EEC (OJ No. L142, 25.5.89, p.11), 91/507/EEC (OJ No. L270, 26.9.91, p.32) and 93/39/EEC (OJ No. L214, 24.8.93, p.22.).

[^f00010]: OJ No. L147, 9.6.75, p.13. The Directive was amended by Directives 83/570/EEC (OJ No. L332, 28.11.83, p.1), 89/341/EEC (OJ No. L142, 25.5.89, p.11) and 93/39/EEC (OJ No. L214, 24.8.1993, p.22); see also Directives 89/342/EEC (OJ No. L142, 25.5.89, p.14), 89/343/EEC (OJ No. L142, 25.5.89, p.16) and 89/381/EEC (OJ No. L181, 28.6.89, p.44), which extend the provisions of Directives 65/65/EEC and 75/319/EEC to vaccines, toxins or serums and allergens, radiopharmaceuticals and products derived from human blood or human plasma.

[^f00011]: OJ No. L142, 25.5.89, p.14.

[^f00012]: OJ No. L142, 25.5.89, p.16.

[^f00013]: OJ No. L181, 28.6.89, p.44.

[^f00014]: OJ No. L113, 30.4.92, p.5.

[^f00015]: OJ No. L113, 30.4.92, p.8.

[^f00016]: OJ No. L297, 13.10.92, p.8.

[^f00017]: OJ No. L214, 24.8.93, p.1.

[^f00018]: S.I. 1971/1450. The relevant amending instruments are S.I. 1972/1200 and 1989/1184 and 2323.

[^f00019]: 1978, c. 30.

[^f00020]: See The Medicines Act 1968, section 132(1) for a definition of “the Gazette”.

[^f00021]: 1968 c. 29; section 2(5) was amended by the Medicines Act 1968, Schedule 5, paragraph 16.

[^f00022]: 1971 c. 69.

[^f00023]: 1987 c. 43.

[^f00024]: 1990 c. 16.

[^f00025]: See article 2 of Council Directive 89/343/EEC.

[^f00026]: S.I. 1978/1006.

[^f00027]: S.I. 1980/1923. The relevant amending instruments are S.I. 1982/28, 1990/1124 and 1994/2411.

[^f00028]: S.I. 1976/1726. The relevant amending instruments are S.I. 1977/996 and 2168, 1978/1140, 1981/1791, 1983/1729, 1985/1558 and 1992/3273.

[^f00029]: S.I. 1977/1055, amended by S.I. 1992/3274.

[^f00030]: S.I. 1991/1474. The relevant amending instruments are S.I. 1992/756 and 1994/691.

[^f00031]: The Annex to Council Directive 75/318/EEC was replaced by Council Directive 91/507/EEC.

[^f00032]: S.I. 1975/762.

[^f00033]: S.I. 1975/2000. The relevant amending instruments are S.I. 1976/1643, 1987/877, and 1994/1402.

[^f00034]: S.I. 1976/1726. The relevant amending instruments are S.I. 1977/996, 1983/1729, 1988/1009 and 1992/3273.

[^f00035]: S.I. 1977/1038. The relevant amending instrument is S.I. 1992/2845.

[^f00036]: S.I. 1977/655.

[^f00037]: S.I. 1978/40.

[^f00038]: S.I. 1980/14. The relevant amending instrument is S.I. 1994/

[^f00039]: S.I. 1980/1923. The relevant amending instruments are S.I. 1982/28, 1990/1124 and 1992/2938.

[^f00040]: S.I. 1980/1924. The relevant amending instruments are S.I. 1982/27, 1989/1852 and 1994/2409.

[^f00041]: S.I. 1981/1011.

[^f00042]: S.I. 1984/1305, to which there are amendments not relevant to these Regulations.

[^f00043]: S.I. 1985/71. The relevant amending instruments are S.I. 1991/1476 and 1992/2596.

[^f00044]: S.I. 1986/144.

[^f00045]: S.I. 1988/1771.

[^f00046]: S.I. 1990/566.

[^f00047]: S.I. 1991/1506.

[^f00048]: S.I. 1993/2538.

[^f00049]: S.I. 1993/3250.

[^f00050]: S.I. 1994/743.

[^f00051]: S.I. 1994/1932.

[^f00052]: S.I. 1994/2328.