The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

Offences

7.  Any holder of a traditional herbal registration who fails promptly to—

(a) take any steps reasonably necessary to take account of technical and scientific progress for the purposes of making any changes or amendments as required by Article 23 of the 2001 Directive; or

(b) introduce any changes or make any amendments that may be required in accordance with that Article or paragraphs 3.2(9) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive; or

(c) provide information to the licensing authority as required by the third or fourth paragraphs of Article 23 of the 2001 Directive; or

(d) submit any application to the licensing authority to make any changes or variation as required by that Article; or

(e) notify the licensing authority if the traditional herbal medicinal product to which the registration relates has not been placed on the market in the United Kingdom for a period of three consecutive years pursuant to regulation 9(4);

shall be guilty of an offence.