Notices

Monographs of the European Pharmacopoeia are distinguished by a chaplet of stars against the title. The term European Pharmacopoeia, used without qualification, means the ninth edition of the European Pharmacopoeia comprising, unless otherwise stated, the main volume, published in 2016, as amended by any subsequent supplements and revisions.

Patents

In this Pharmacopoeia certain drugs and preparations have been included notwithstanding the existence of actual or potential patent rights. In so far as such substances are protected by Letters Patent their inclusion in this Pharmacopoeia neither conveys, nor implies, licence to manufacture.

Effective dates

New and revised monographs of national origin enter into force on 1 January 2018. The monographs are brought into effect under regulation 320(2) of the Human Medicines Regulations 2012.

Monographs of the European Pharmacopoeia have previously been published by the European Directorate for the Quality of Medicines & HealthCare, in accordance with the Convention on the Elaboration of a European Pharmacopoeia, and have been brought into effect under European Directives 2001/82/EC, 2001/83/EC and 2003/63/EC, as amended, on medicines for human and veterinary use.