The Human Medicines Regulations 2012

PART 4 Exceptions to Schedule

31.  This Schedule does not apply to an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration if, at any time during the period beginning with the date on which the application is made and ending with the date on which the licensing authority gives a decision on the application, there is an authorisation, certificate or registration in force in respect of the medicinal product in question in any EEA State.

32.  This Schedule does not apply to an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration if the application has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive.

33.  This Schedule ceases to apply if at any time the matter in question is referred to the Committee for Medicinal Products for Human Use or the Committee for Herbal Medicinal Products under Article 30 or 31 of the 2001 Directive for the application of the procedure laid down in Articles 32 to 34 of that Directive.

34.  This Schedule does not apply to an application for a UK marketing authorisation or certificate of registration if—

(a) the licensing authority declines to assess the application on the ground that—

(i) an application for an authorisation or registration in respect of the same medicinal product is being examined in another EEA State, and

(ii) the application to the licensing authority has not been submitted in accordance with Article 28(1) and (3) of the 2001 Directive; or

(b) the licensing authority rejects the application on the ground that—

(i) the medicinal product in question has an authorisation or registration in another EEA State, and

(ii) the application to the licensing authority has not been submitted in accordance with Article 28(1) and (2) of the 2001 Directive.

35.  This Schedule does not apply to an application for a traditional herbal registration in relation to which either of the conditions in Article 16d(1) of the 2001 Directive is met if—

(a) the licensing authority declines to assess the application on the ground that—

(i) an application for a registration in respect of the same medicinal product is being examined in another EEA State, and

(ii) the application to the licensing authority has not been submitted in accordance with Article 28(1) and (3) of the 2001 Directive; or

(b) the licensing authority rejects the application on the ground that—

(i) the medicinal product in question has a registration in another EEA State, and

(ii) the application to the licensing authority has not been submitted in accordance with Article 28(1) and (2) of the 2001 Directive.

36.  This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a UK marketing authorisation that—

(a) was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure);

(b) was granted before 1st January 1995 by member States in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(1); or

(c) was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

37.  This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a certificate of registration that was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure).

38.  This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a traditional herbal registration that—

(a) was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure); or

(b) was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the registration.

39.  This Schedule does not apply if—

(a) the licensing authority refuse to grant an application for a traditional herbal registration;

(b) the application was referred to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive; and

(c) the Committee for Herbal Medicinal Products did not support the grant of the application.

(1)

OJ No L 15, 17.1.1987. p.38.