PART 15British Pharmacopoeia
Specified publications321
1
In this regulation “specified publication” means any of the following—
a
the European Pharmacopoeia;
b
the British Pharmacopoeia;
c
the Cumulative List of Recommended International Nonproprietary Names;
d
a compendium prepared and published under regulation 317; or
e
a list of names prepared and published under regulation 318.
2
Paragraph (3) applies if an authorisation refers to a specified publication, but not to a particular edition of the publication.
3
Where this paragraph applies, in order to determine whether anything done at a time when the authorisation is in force is done in accordance with the authorisation, the reference to a specified publication is to be construed as a reference to the edition of the specified publication in force at that time, unless the authorisation expressly provides otherwise.
4
In paragraph (3) the reference to the edition of a specified publication in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time.
5
In this regulation “authorisation” means any of the following—
a
a manufacturer’s licence;
b
a wholesale dealer’s licence;
c
a marketing authorisation;
d
an Article 126a authorisation;
e
a certificate of registration; or
f
a traditional herbal registration.