The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992

Insertion of Schedule 1A to the Principal Regulations

4.  After Schedule 1 to the Principal Regulations there shall be inserted the following Schedule—

Regulation 4A

“SCHEDULE 1A REQUIREMENTS AS TO THE PARTICULARS ON AN APPLICATION FOR THEGRANT OF A PRODUCT LICENCE IN RESPECT OF CERTAIN PRODUCTS

PART I BLOOD PRODUCTS

1.   In the particulars required by Part I or Part II of Schedule I to these Regulations the common or scientific name of the active constituents shall be mentioned at least once (though they may be abbreviated in other references).

2.   The statement required by paragraph 12 of Part I of, or by paragraph 13 of Part II of Schedule 1 to these Regulations shall—

(a) as respects quantitative composition, be expressed by mass, by international units or by units of biological activity as appropriate to the product;

(b) include particulars relating to biological activity and shall include the composition of the product (expressed in accordance with sub-paragraph (a) of this paragraph).

PART II VACCINES, TOXINS, SERUMS, OR ALLERGEN PRODUCTS

1.   The name or proposed name of the product under which the product is to be sold or supplied shall include the common or scientific name of the active constituents.

2.   The statement of qualitative and quantitative composition shall include particulars relating to biological activity or to protein content and the statement of the composition of the product shall be expressed in terms either of biological activity or of protein content.

3.   The statement of the quantitative particulars shall be expressed by mass, in international units, by units of biological activity or by specific protein content as appropriate to the product concerned.

4.   The particulars shall include a description of any special precautions to be taken by persons handling the product and persons administering the product to patients together with any precautions to be taken by the patient.

PART III RADIOPHARMACEUTICALS

The particulars shall include—

(a) a statement of the details of internal radiation dosimetry;

(b) a statement specifying the instructions for extemporaneous preparation and quality control of the product and where appropriate, maximum storage time during which any intermediate preparation or the completed product will conform with its specifications; and

(c) if the application is in respect of a radiopharmaceutical which is a generator—

(i) a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nuclide preparation; and

(ii) qualitative and quantitative particulars of the eluate or the sublimate.”.