Regulation 6 Amendment of the Schedule to the principal Regulations

The Schedule to the principal Regulations shall be amended in accordance with the following paragraphs of this regulation.

After paragraph 2 there shall be inserted the following paragraph—

“2A

In relation to medicinal products for human use, the manufacturer shall provide and maintain a designated quality control department having authority in relation to quality control and being independent of all other departments.”;

After paragraph 3, there shall be inserted the following paragraph—

“3A

In relation to medicinal products for human use, the manufacturer shall maintain an effective pharmaceutical quality assurance system involving the active participation of the management and personnel of the different services involved.”.

In paragraph 7, after the word “destroyed” there shall be inserted the following—

“(a)

in relation to a medicinal product for human use, for a period of five years from the date of release of the relevant batch, or for a period of one year after the expiry date of the relevant batch, whichever expires later,

(b)

in any other case,”.

After paragraph 7 there shall be inserted the following paragraphs—

“7A

In relation to medicinal products for human use to which a product licence relates, the manufacturer shall keep readily available for examination by a person authorised by the licensing authority, samples of—

(a)

each batch of finished products for at least a period of one year after their expiry date; and

(b)

starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which the relevant starting materials formed part;

except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.

7B

(1)

The manufacturer shall implement a system for recording and reviewing complaints in relation to medicinal products for human use to which a product licence relates together with an effective system for recalling promptly and at any time the medicinal products in the distribution network.

(2)

The manufacturer shall record and investigate all complaints described in sub-paragraph (1) of this paragraph and shall immediately inform the licensing authority of any defect which could result in a recall from sale, supply or exportation or in an abnormal restriction on such sale, supply or exportation.”.