The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

Applications for the grant or renewal of a traditional herbal registration

5.—(1) Every application for the grant or renewal of a traditional herbal registration shall be made in writing in accordance with the relevant Community provisions, subject to the rules of Community law relating to parallel imports, and the applicant shall comply with so much of the relevant Community provisions as contain requirements for applications as are applicable to the application or the consideration of it.

(2) Every application shall be made in writing, shall be signed by or on behalf of the applicant and shall, unless the licensing authority otherwise direct, be accompanied by any fee which may be payable in connection with that application.

(3) One copy of the application and of any accompanying material shall be supplied to the licensing authority in the English language and where the application or any accompanying material has been translated from another language, one copy of the application or the accompanying material, as the case may be, shall also be supplied in the original language.

(4) An application for the grant of a traditional herbal registration shall include a statement indicating—

(a) whether the herbal medicinal product is one that should be available—

(i) only from a pharmacy; or

(ii) on general sale; and

(b) what, if any, provisions of the traditional herbal registration are proposed concerning the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product).

(5) The applicant for the grant or renewal of a traditional herbal registration must be established in the Community.

(6) An application for the renewal of a traditional herbal registration shall be made not later than 6 months before the date on which the existing traditional herbal registration expires.