Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005
| Jurisdiction | UK Non-devolved |
| Citation | SI 2005/2753 |
| Year | 2005 |
2005 No. 2753
MEDICINES
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005
Made 6th October 2005
Laid before Parliament 7th October 2005
Coming into force 30th October 2005
The Secretary of State, being a Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), makes the following Regulations:
Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 and shall come into force on 30th October 2005.
(2) In these Regulations “the Homoeopathic Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19943.
Amendment of regulation 1 of the Homoeopathic Regulations
2.—(1) Regulation 1 of the Homoeopathic Regulations (citation, commencement and interpretation) is amended as follows.
(2) In paragraph (2)—
(a)
(a) after the definition of “certificate of registration” insert the following definition—
““concerned member State” means an EEA state, the competent authority of which receives an application to obtain recognition, according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive, of an EC registration;”;
(b)
(b) in the definition of “the 2001 Directive”4after “as amended” insert—
“by—
(a) Directive 2002/98/ECof the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components5,
(b) Commission Directive 2003/63/ECamending Directive 2001/83/ECon the Community code relating to medicinal products for human use6,
(c) Directive 2004/24/ECof the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/ECon the Community code relating to medicinal products for human use7, and
(d) Directive 2004/27/ECof the European Parliament and of the Council amending Directive 2001/83/ECon the Community code relating to medicinal products for human use8;”;
(c)
(c) after the definition of “the 2001 Directive” insert the following definitions—
““EEA State” means a Member State, Norway, Iceland or Liechtenstein;
“EC registration” means a registration granted by a competent authority of an EEA State in accordance with the procedure set out in Article 14 of the 2001 Directive;”;
(d)
(d) in the definition of “homoeopathic medicinal product” omit “products,” and “or compositions”; and
(e)
(e) after the definition of “homoeopathic medicinal product” insert the following definition—
““set of applications” means—
(a) a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or
(b) a number of applications to competent authorities of other EEA States for EC certificates of registration relating to a single certificate of registration, where those applications all have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive.”.
(3) In paragraph (3), for sub-paragraph (c) substitute the following sub-paragraph—
“(c)
“(c) any expressions which are also used in the 2001 Directive shall have the same meaning as they have in the 2001 Directive and related expressions shall be construed accordingly.”.
Amendment of regulation 2 of the Homoeopathic Regulations
3. In regulation 2 of the Homoeopathic Regulations (application) after “homoeopathic medicinal products for human use” insert “to which the 2001 Directive applies and that fulfil the conditions laid down in Article 14(1) of the 2001 Directive”.
Insertion of regulation 2A of the Homoeopathic Regulations
4. After regulation 2 of the Homoeopathic Regulations insert the following regulation—
“Responsibility for Member States' functions in relation to homoeopathic medicinal products
2A.—(1) In so far as they relate to homoeopathic medicinal products to which these Regulations apply and fall to be performed by, or by any authority of, the United Kingdom, the functions of a Member State, or of the competent authority of a Member State, under any of the provisions of the 2001 Directive shall, subject to paragraph (2), be performed by the licensing authority.
(2) Paragraph (1) shall not apply in so far as any such functions fall to be performed by the exercise of any powers or duties which are conferred by any provision of these Regulations, or by any provision of the Act as applied by these Regulations, on a person or body other than the licensing authority.”.
Amendment of regulation 4 of the Homoeopathic Regulations
5. In regulation 4 of the Homoeopathic Regulations (application for certificate), for paragraph (1) substitute the following paragraph—
“1 Every application for the grant or renewal of a certificate of registration shall be made in writing in accordance with the provisions of the 2001 Directive and the applicant shall comply with so much of the provisions of the 2001 Directive as contain requirements for applications, as are applicable to the application or the consideration of it.”.
Amendment of regulation 5 of the Homoeopathic Regulations
6.—(1) Regulation 5 of the Homoeopathic Regulations (determination of application for certificate) is amended as follows.
(2) For paragraph (1) substitute the following paragraph—
“1 The licensing authority shall consider every application for the grant of a certificate of registration in accordance with the provisions of the 2001 Directive and shall grant or refuse to grant the certificate in accordance with those provisions.”.
(3) Omit paragraphs (2) and (3).
(4) For paragraph (4) substitute the following paragraph—
“4 Schedule 5 shall have effect to regulate the procedure for receiving advice and representations before granting or refusing to grant a certificate of registration.”.
(5) Omit paragraphs (5) and (6).
Amendment of regulation 7 of the Homoeopathic Regulations
7. Omit regulation 7 of the Homoeopathic Regulations (requirements in respect of controls).
Insertion of regulation 7A of the Homoeopathic Regulations
8. After regulation 7 of the Homoeopathic Regulations insert the following regulation—
“Obligations of holders of certificates of registration, and offences by holders of certificates of registration and other persons
7A.—(1) Every holder of a certificate of registration shall comply with all obligations which relate to him by virtue of the 2001 Directive.
(2) The holder of a certificate of registration shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any homoeopathic medicinal product to which the certificate relates.
(3) Schedule 6 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, certificates of registration and other persons arising under the 2001 Directive.
(4) Where, by or under any provision of the 2001 Directive or of these Regulations, a person is required to provide any information or furnish any document to the licensing authority and no time is specified in that provision within which that obligation is to be performed, it shall be performed within such time as may be specified in a written notice served on that person by the licensing authority.”.
Amendment of regulation 8 of the Homoeopathic Regulations
9.—(1) Regulation 8 of the Homoeopathic Regulations (duration and renewal of certificates) is amended as follows.
(2) In paragraph (1)—
(a)
(a) before “A certificate of registration” insert “Subject to paragraph 2A,”; and
(b)
(b) omit the words from “or the date from which” to the end.
(3) In paragraph (2)—
(a)
(a) after “the licensing authority” insert “in accordance with the provisions of the 2001 Directive”; and
(b)
(b) omit the words from “for five years” to the end.
(4) After paragraph (2) insert the following paragraph—
“2A A certificate of registration shall cease to be valid if the homoeopathic medicinal product in respect of which it was granted is not placed on the market in the UK for a period of three consecutive years.”.
(5) Omit paragraphs (3) and (4).
(6) After paragraph (4) insert the following paragraph—
“5 Schedule 5 shall have effect to regulate the procedure for receiving advice and representations before renewing or refusing to renew a certificate of registration.”.
Amendment of regulation 9 of the Homoeopathic Regulations
10. For regulation 9 of the Homoeopathic Regulations (suspension and revocation) substitute the following regulation—
“Suspension, variation and revocation
9.—(1) The licensing authority may and, where appropriate shall, subject to and in accordance with the provisions of the 2001 Directive, revoke, suspend or vary a certificate of registration.
(2) Schedule 5 shall have effect to regulate the procedure for receiving advice and...
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