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

Insertion of Parts III, IV and V into the Schedule to the Renewal Regulations

7.  After Part II of the Schedule to the Renewal Regulations, there shall be inserted the following—

“PART III FURTHER PROVISIONS AS TO THE PARTICULARS WHICH ARE TO BE CONTAINED IN OR ACCOMPANY AN APPLICATION FOR THE RENEWAL OF A PRODUCT LICENCE IN RESPECT OF BLOOD PRODUCTS FOR HUMAN USE

1.   In the particulars required by Part I or Part II of this Schedule 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 5(a) and (b) of Part I of, or by paragraph 7(a) and (b) of Part II of this Schedule 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 IV FURTHER PROVISIONS AS RESPECTS THE PARTICULARS TO BE CONTAINED IN OR ACCOMPANY AN APPLICATION FOR THE RENEWAL OF A PRODUCT LICENCE FOR A VACCINE, TOXIN, SERUM OR ALLERGEN PRODUCT FOR HUMAN USE

1.   The particulars required by paragraph 4 of Part I of, or by paragraph 7(a) and (b) of Part II of this Schedule shall include the name or proposed name of the product under which the product is to be sold or supplied which shall include the common or scientific name of the active constituents.

2.   The particulars 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 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 V FURTHER REQUIREMENTS AS RESPECTS THE PARTICULARS WHICH ARE TO BE CONTAINED IN OR ACCOMPANY AN APPLICATION FOR THE RENEWAL OF A PRODUCT LICENCE FOR A RADIOPHARMACEUTICAL FOR HUMAN USE

The particulars required by paragraphs 5(a) and (c) of Part I of, or by paragraph 7(a) and (c) of Part II of the Schedule to these Regulations 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.”.