The Human Medicines (Amendment) Regulations 2013
| Jurisdiction | UK Non-devolved |
| Citation | SI 2013/1855 |
2013No. 1855
MEDICINES
The Human Medicines (Amendment) Regulations 2013
22ndJuly2013
29thJuly2013
The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in the exercise of the powers conferred by-
section 2(2) and (5) of the European Communities Act 1972( 1), having been designated for the purposes of section 2(2) of that Act in relation to medicinal products( 2);
section 58(1), (4), (4A) and (5) of the Medicines Act 1968( 3);
section 1(1) and (2) of the Medicines Act 1971( 4) or, in the case of the Minister, the powers conferred by those provisions and now vested in him( 5).
PART 1
Introduction
Citation, commencement and interpretation
1. (1) These Regulations may be cited as the Human Medicines (Amendment) Regulations 2013 and subject to paragraph (2) shall come into force on 20th August 2013.
(2) Regulation 28 shall come into force one year after the date of publication in the Official Journal of the European Union of the implementing acts referred to in Article 85c(3) (provisions as to the sale at a distance of medicinal products) of Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use( 6).
(3) Regulation 31 shall come into force immediately after regulations 32 to 35.
PART 2
Amendment of the Human Medicines Regulations 2012
Part 2: General
2. The Human Medicines Regulations 2012( 7) are amended in accordance with this Part.
Amendment of regulation 8
3. In regulation 8 (general interpretation)-
(a) in paragraph (1)-
(i) after the definition of "the 2001 Directive" insert-
""active substance" means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;";
(ii) for the definition of "assemble" substitute-
""assemble", in relation to a medicinal product or an active substance, includes the various processes of dividing up, packaging and presentation of the product or substance, and "assembly" has a corresponding meaning;";
(iii) after the definition of "the British Pharmacopoeia" insert-
""brokering" means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;";
(iv) after the definition of "the European Pharmacopoeia" insert-
""excipient" means any constituent of a medicinal product other than the active substance and the packaging material;";
(v) for the definition of "export" substitute-
""export" means export, or attempt to export, from the United Kingdom, whether by land, sea or air;";
(vi) before the definition of "the Good Manufacturing Practice Directive" insert-
""falsified medicinal product" means any medicinal product with a false representation of-
(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used;
"Fees Regulations" means the Medicines (Products for Human Use) (Fees) Regulations 2013( 8);";
(vii) after the definition of "immediate packaging" insert-
""import" means import, or attempt to import, into the United Kingdom, whether by land, sea or air;";
(viii) after the definition of "pharmacy medicine", insert-
""physiotherapist independent prescriber" means a person-
(a) who is a registered physiotherapist; and
(b) against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;
"podiatrist independent prescriber" means a person-
(a) who is a registered podiatrist; and
(b) against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a podiatrist independent prescriber;";
(b) after paragraph (7), insert-
"(8) References in these Regulations to-
(a) good manufacturing practice for active substances relate to the principles and guidelines for good manufacturing practice adopted by the European Commission under the third paragraph of Article 47( 9) of the 2001 Directive;
(b) good distribution practice for active substances relate to the guidelines on good distribution practices for active substances adopted by the European Commission under the fourth paragraph of Article 47 of the 2001 Directive."
Insertion of regulation A17
4. In Part 3, before the heading "Manufacturing and wholesale dealing" there is inserted-
"Manufacture and distribution of medicinal products and active substances".
CHAPTER 1
Interpretation
Interpretation
CHAPTER 2
A17. In this Part "manufacture", in relation to an active substance, includes any process carried out in the course of making the substance and the various processes of dividing up, packaging, and presentation of the active substance.
Substitution of regulation 18
5. For regulation 18 (wholesale dealing in medicinal products) substitute-
"Wholesale dealing in medicinal products
18.
(1) A person may not except in accordance with a licence (a "wholesale dealer's licence")-
(a) distribute a medicinal product by way of wholesale dealing; or
(b) possess a medicinal product for the purpose of such distribution.
(2) Paragraph (1)-
(a) does not apply-
(i) to anything done in relation to a medicinal product by the holder of a manufacturer's licence in respect of that product,
(ii) where the product concerned is an investigational medicinal product, or
(iii) if the product is a radiopharmaceutical in which the radionuclide is in the form of a sealed source; and
(b) is subject to regulation 19.
(3) Distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, is not to be taken to be in accordance with a wholesale dealer's licence unless the distribution is carried on, or as the case may be the product held, at premises located in the UK and specified in the licence.
(4) In these Regulations a reference to distributing a product by way of wholesale dealing is a reference to-
(a) selling or supplying it; or
(b) procuring or holding it or exporting it for the purposes of sale or supply,
to a person who receives it for a purpose within paragraph (5).
(5) Those purposes are-
(a) selling or supplying the product; or
(b) administering it or causing it to be administered to one or more human beings,
in the course of a business carried on by that person.
(6) A wholesale dealer's licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, unless a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product but this-
(a) does not apply in relation to distribution by a person to a person in a third country; and
(b) is subject to the exceptions in regulation 43(6).
(7) In paragraph (6), "marketing authorisation" means-
(a) a marketing authorisation issued by a competent authority of a member State in accordance with the 2001 Directive; or
(b) an EU marketing authorisation."
Amendment of regulation 19
6. In regulation 19 (exemptions from requirement for wholesale dealers licence) omit paragraph (5).
Amendment of regulation 20
7. In regulation 20(1) (mixing of medicines)-
(a) after sub-paragraph (c) insert-
"(ca) physiotherapist independent prescriber;
(cb) podiatrist independent prescriber;";
(b) in sub-paragraph (d)(iii) omit "or";
(c) for sub-paragraph (d)(iv) substitute-
"(iv) pharmacist independent prescriber,
(v) physiotherapist independent prescriber, or
(vi) podiatrist independent prescriber; or".
Amendment of regulation 27
8. In regulation 27 (procedure where licensing authority proposes to suspend, revoke or vary licence), for paragraph (5) substitute-
"(5) If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)-
(a) Schedule 5 has effect; and
(b) the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations."
Amendment of regulation 34
9. In regulation 34 (offences: breach of regulations and false information and defence concerning starting materials)-
(a) in paragraph (1), for ", 18(1) or 32" substitute "or 18(1)";
(b) in paragraphs (4) and (5), for "37(2)(b)" substitute "37(3)" .
Amendment of regulation 36
10. In regulation 36 (conditions for manufacturer's licence), in paragraph (2) for "37(2)(b)" substitute "37(3)".
Substitution of regulation 37
11. For regulation 37 (manufacturing and assembly) substitute-
"Manufacturing and assembly
37.
(1) This regulation applies in relation to a manufacturer's licence relating to the manufacture or assembly of medicinal products.
(2) The licence holder must comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive.
(3) Unless paragraph (10) applies, the licence holder shall use active substances as starting materials only if-
(a) those substances have been manufactured in accordance with good manufacturing practice for active substances; and
(b) those...
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