The Human Medicines Regulations 2012

Regulation 41

SCHEDULE 7U.K.Qualified persons

This Atodlen has no associated Memorandwm Esboniadol

PART 1U.K.Qualification requirements for qualified person

1.  A person must satisfy the requirements in paragraphs 2 and 8 or, alternatively, the requirements in paragraphs 7 and 8, of this Schedule before acting as a qualified person (but this is subject to Part 2).U.K.

2.  The person must have a degree, diploma or other formal qualification which satisfies the requirements of this Part, in one of the following subjects—U.K.

(a)pharmacy;

(b)medicine;

(c)veterinary medicine;

(d)chemistry;

(e)pharmaceutical chemistry and technology; or

(f)biology,

but this paragraph is subject to paragraph 7.

3.  A qualification satisfies the requirements of this Part if it is awarded on completion of a university course of study, or a course recognised as equivalent by [F1the licensing authority], which—U.K.

(a)satisfies the minimum requirements specified in paragraph 4; and

(b)extends over a period of at least four years of theoretical and practical study of a subject specified in paragraph 2 (but this is subject to paragraphs 5 and 6).

Textual Amendments

4.—(1) A course should include at least the following core subjects—U.K.

(a)experimental physics;

(b)general and inorganic chemistry;

(c)organic chemistry;

(d)analytical chemistry;

(e)pharmaceutical chemistry, including analysis of medicinal products;

(f)general and applied medical biochemistry;

(g)physiology;

(h)microbiology;

(i)pharmacology;

(j)pharmaceutical technology;

(k)toxicology; and

(l)pharmacognosy.

(2) The subjects mentioned in sub-paragraph (1) should be balanced in such a way as to enable the person to fulfil the obligations specified in Part 3 of this Schedule.

5.  If the course referred to in paragraph 3 is followed by a period of theoretical and practical training of at least one year, including a training period of at least six months in a pharmacy open to the public and a final examination at university level, the minimum duration of the course is three and a half years.U.K.

6.  If two university courses, or courses recognised as of university equivalent standard, co-exist, one of which extends over four years and the other over three years, the three-year course is to be treated as fulfilling the condition as to the duration of the course in paragraph 3, provided that [F2the licensing authority] recognises the formal qualifications gained from each course as being equivalent.U.K.

Textual Amendments

7.  If the person's formal qualifications do not satisfy the requirements of this Part, the person may act as a qualified person if the licensing authority is satisfied, on the production of evidence, that the person has adequate knowledge of the subjects specified in paragraph 4(1).U.K.

8.—(1) The person must (subject to sub-paragraph (2)) have at least two years' practical experience in an undertaking authorised to manufacture medicinal products of—U.K.

(a)qualitative analysis of medicinal products;

(b)quantitative analysis of active substances; and

(c)the testing and checking necessary to ensure the quality of medicinal products.

(2) But—

(a)if the person has completed a university course lasting at least five years, the minimum period of practical experience under this paragraph is one year; and

(b)if the person has completed a university course lasting at least six years, the minimum period of practical experience under this paragraph is six months.

PART 2U.K.Qualified persons with long experience

9.—(1) This paragraph applies to a person who has acted as a qualified person since the coming into force of Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products M1.U.K.

(2) A person to whom this paragraph applies may continue to act as a qualified person.

Marginal Citations

M1OJ No L 147, 9.6.1975, p.13, no longer in force.

10.—(1) This paragraph applies to a person who—U.K.

(a)holds a degree, diploma or other formal qualification in a scientific discipline awarded on completion of a university course or course recognised as equivalent; and

(b)began the course before 21 May 1975.

(2) A person to whom this paragraph applies may act as a qualified person provided that sub-paragraph (3) (and, where applicable, paragraph 11) is satisfied.

(3) This sub-paragraph is satisfied if, for at least two years before 21 May 1985, the person has carried out one of the following activities in an undertaking authorised to manufacture medicinal products—

(a)production supervision;

(b)qualitative and quantitative analysis of active substances; or

(c)testing and checking, under the direct supervision of the qualified person in respect of the undertaking, to ensure the quality of the medicinal products.

11.  If a person to whom paragraph 10 applies acquired the practical experience mentioned in paragraph 10(3) before 21 May 1965, the person must complete a further one year's practical experience of the kind specified in that paragraph immediately before the person may act as a qualified person.U.K.

PART 3U.K.Obligations of qualified person

12.—[F3(1)] [F4In Great Britain, the qualified person] is responsible for securing—

(a)that each batch of medicinal products manufactured in [F5Great Britain] has been manufactured and checked in accordance with these Regulations and the requirements of the [F6UK marketing authorisation], certificate of registration or traditional herbal registration [F7, or an equivalent authorisation,] relating to those products; F8... [F9and]

(b)in the case of [F10medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import], that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the [F11UK marketing authorisation], certificate of registration or traditional herbal registration [F12, or an equivalent authorisation,] relating to those products; [F13and]

F14(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F15(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.]

Textual Amendments

F8Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)

F13Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)

[F1612A.—(1) In Northern Ireland, the qualified person is responsible for securing—U.K.

(a)that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b)in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(c)in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.]

[F17(2) This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.]

Textual Amendments

13.—(1) This paragraph applies [F18in Northern Ireland] where—U.K.

(a)a medicinal product which has undergone the controls referred to in [F19paragraph 12A in a member State is imported to Northern Ireland]; and

(b)each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph [F2012A].

Textual Amendments

14.—(1) This paragraph applies where—U.K.

(a)medicinal products are imported [F21into Great Britain from a country other than an approved country for import or into Northern Ireland] from a country other than an EEA State; and

[F22(b)appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i)the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa)in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb)in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii)the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.]

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12 [F23or 12A].

[F24(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

(a)the country's rules for good manufacturing practice;

(b)the regularity of inspections to verify compliance with good manufacturing practice;

(c)the effectiveness of enforcement of good manufacturing practice;

(d)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e)any on-site review of that country's regulatory system undertaken by the licensing authority;

(f)any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g)any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a)review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b)if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

(c)undertake such a review at least every three years beginning with the date on which the country is included in that list.]

Textual Amendments

15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.U.K.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.