The Human Medicines Regulations 2012

Submission of mock-ups of packaging and leaflets to licensing authority

267.—(1) At the time when a person applies for a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, the person must submit to the licensing authority—

(a) one or more mock-ups of the outer packaging and immediate packaging proposed for the product; and

(b) a draft package leaflet.

(2) If the application is for a marketing authorisation, Article 126a authorisation or traditional herbal registration, the person must also provide to the licensing authority the results of assessments of the packaging and package leaflet carried out in co-operation with target patient groups.

(3) The licensing authority must refuse the application for a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration if—

(a) the packaging or the package leaflet does not comply with the requirements of this Part; or

(b) (in relation to an application for a marketing authorisation, Article 126a authorisation or traditional herbal registration) the information on the packaging or the package leaflet does not accord with the particulars listed in the summary of the product characteristics.

(4) If the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a product wishes to make changes to the packaging or the package leaflet (other than a change connected with the summary of the product characteristics), the proposed change must be submitted to the licensing authority in accordance with paragraph (5).

(5) In the circumstances in paragraph (4) the holder must submit to the licensing authority such of the following as are affected by the proposed change—

(a) one or more mock-ups of the outer packaging and immediate packaging of the product showing the proposed change; and

(b) a draft package leaflet showing the proposed change.

(6) If the licensing authority has not refused a proposed change within the period of 90 days beginning with the date of the submission, the applicant may make the change.