Regulation 104 Consideration of application

(1)

The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a certificate of registration before the end of the period of 210 days beginning immediately after the day on which an application for the certificate is submitted in accordance with regulation 103.

(2)

If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a)

beginning with the date on which the request is made; and

(b)

ending with the date on which the information or material is provided.

(3)

The licensing authority may grant a certificate only if, having considered the application and the accompanying material, the authority thinks that—

(a)

the risks to the health of patients or of the public associated with the product do not outweigh any beneficial effects of the homoeopathic medicinal product in question;

(b)

the application and the accompanying material complies with regulation 103; and

(c)

the product's qualitative or quantitative composition is as described in the application and the accompanying material.

(4)

Schedule 11 makes provision about advice and representations in relation to an application for the grant of a certificate of registration.

(5)

This regulation does not apply to an application that—

(a)

has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or

(b)

has been referred to the Committee for Medicinal Products for Human Use for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.

(6)

An application to which paragraph (5) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.

F1(7)

In the case of an application under the unfettered access route, the licensing authority may grant a COR(GB) (notwithstanding paragraph (3)) where the licensing authority—

(a)

has considered the application under the unfettered access route and the accompanying material,

(b)

is satisfied that the applicant has complied with the application requirements, and

(c)

is satisfied that the conditions in regulation 103(1A) will continue to be met.

(8)

The licensing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.

Annotations

Textual amendments

F1: Reg. 104(7)(8) inserted (31.12.20200 by S.I. 2019/775, reg. 100(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 77)