The Medicines for Human Use (Clinical Trials) Regulations 2004

Variation of manufacturing authorisation

44.—(1) The licensing authority may vary a manufacturing authorisation, whether on the application of the holder of the authorisation or otherwise.

(2) Subject to the following provisions of this regulation, if the holder of a manufacturing authorisation makes a valid application to vary the manufacturing authorisation the licensing authority shall consider the application and—

(a) in a case where the effect of the variation would be to change the—

(i) the types of investigational medicinal products,

(ii) the manufacturing, assembling or importation operations,

(iii) the premises,

(iv) the technical equipment and control facilities,

in respect of which the authorisation has been granted, may vary or refuse to vary the authorisation within a period not exceeding 30 days from the date the application is received;

(b) in any other case, may vary or refuse to vary the authorisation within such period as the licensing authority consider appropriate.

(3) If the application falls within paragraph (2)(a), but it appears to the licensing authority to be necessary to conduct an inspection of any premises to which the variation relates, the authority may vary or refuse to vary the authorisation within a period not exceeding 90 days from the date the application is received.

(4) Following receipt of a valid application to vary a manufacturing authorisation, the licensing authority may give a notice in writing to the applicant requesting him to provide further information relating to the contents of the application or any particulars relevant to the application.

(5) Where the licensing authority give a notice pursuant to paragraph (4), and a period specified in paragraph (2)(a) or paragraph (3) applies, that period shall be suspended from the date the notice is given and shall recommence only on receipt of the information requested.

(6) The provisions of Schedule 8 shall have effect where the licensing authority propose to vary a manufacturing authorisation otherwise than on the application of the holder of the authorisation.

(7) Where the licensing authority—

(a) vary a manufacturing authorisation, otherwise than in accordance with a valid application by the holder of the authorisation; or

(b) after consideration of such an application, refuse to vary a manufacturing authorisation,

the licensing authority shall notify the holder of that authorisation in writing, stating the reasons for their decision.

(8) In this regulation, “valid application” means an application—

(a) made to the licensing authority;

(b) in writing and signed by or on behalf of the applicant;

(c) specifying the variation requested by the applicant;

(d) accompanied by—

(i) such particulars as are necessary to enable the licensing authority to consider the application, and

(ii) any fee which may be payable in connection with that application under the Medicines (Products for Human Use—Fees) Regulations 1995(1); and

(e) where the application, and any accompanying material, is in the English language.

(1)

S.I. 1995/1116.