S.L. 549.60 Art. 5Applicability of regulations 6 to 10. S.L. 458.34

(1) Regulations 6 to 10 shall not apply to medicinal substances and compounds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised through the Medicines (Marketing

Authorisation) Regulations, and Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, which provide:

(a) for a specific environment risk assessment in accordance with Schedule II and on the basis of the type of information specified in Schedule III without prejudice to additional requirements provided for by the said legislation;

(b) for explicit consent prior to release;

(c) for a monitoring plan in accordance with the relevant parts of Schedule III, with a view to detecting the effects of the GMO or GMOs on human health or the environment;

(d) in an appropriate manner for requirements relating to treatment of new items of information, information to the public, information on the results of releases, and exchanges of information at least equivalent to those contained in these regulations and in the measures taken in accordance therewith.

(2) Assessment of the risks to the environment presented by such substances and compounds shall be carried out, in accordance with the provisions of Article 5 of the Directive.