Commentaries: Annex 2

(Art. 4 para. 2, 8 para. 4)

Rules of Good Manufacturing Practice for medicinal products in small quantities

The provisions of Chapters 20.1 and 20.2 of the Pharmacopoea Helvetica¹(Ph. Helv.) apply as rules of Good Manufacturing Practice for small quantities of medicinal products.

The Pharmacopoea Helvetica is published by Swissmedic and can be obtained from FOBL, Distribution of Federal Publications, 3003 Bern, www.bundespublikationen.admin.ch, at the conditions shown in FeeO-FedPubs (SR 172.041.11 ). ↩

Annex 2

Rules of Good Manufacturing Practice for medicinal products in small quantities

Footnotes