- Status
- In Force
What it defines
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
5 other provisions — procedural and definitional
s.001
Citation, commencement and interpretation
s.002
Application of these Regulations
s.003
Manner of applications
s.004
Material to be contained in or accompany an application
s.005
Amendment of the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971
Schedules
Schedules
0 of 33 shown33 other schedules
s.sch001
(a) The name or corporate name of and the permanent...
s.sch001
A copy of the manufacturing authorisation as defined in Article...
s.sch001
A copy of any authorisation obtained in a member State...
s.sch001
An expert’s report (stating, where applicable, the grounds for using...
s.sch001
Brief information about the educational background, training and occupational experience...
s.sch001
One or more samples or mock-ups of the sales presentation,...
s.sch001
A statement of the number of volumes of documentation submitted...
s.sch001
A statement as to any samples provided.
s.sch001
Where the applicant is, by virtue of paragraph 8 above,...
s.sch001
Where the applicant is, by virtue of paragraph 8 above,...
s.sch001
A statement indicating— (a) which of the following should apply...
s.sch001
The name of the product, that is to say, the...
s.sch001
If the product is already authorised in other countries—
s.sch001
In relation to any generator to which Article 3 of...
s.sch001
Where the applicant, in relation to all or any particular...
s.sch001
Where the licence applied for is required solely for the...
s.sch001
A statement indicating that the applicant agrees that the licence...
s.sch001
All other information which is relevant to the evaluation of...
s.sch001
The qualitative and quantitative particulars of all the constituents of...
s.sch001
A brief description of the method of preparation.
s.sch001
Particulars of the therapeutic indications, contra-indications and side-effects.
s.sch001
Particulars of the posology, pharmaceutical form, method and route of...
s.sch001
A description, drawn up and signed by experts, of the...
s.sch001
Subject to Schedule 2, particulars, drawn up and signed by...
s.sch001
A summary of the product characteristics which shall contain the...
s.sch002
Subject to paragraphs 2 to 4 below, the applicant shall...
s.sch002
Notwithstanding paragraph 1 above, the applicant shall provide particulars of...
s.sch002
Where the product is a new medicinal product containing known...
s.sch002
The applicant shall not be entitled by virtue of the...
s.sch002
Subject to compliance with paragraphs 19(a) and 22 of Schedule...
s.sch002
The applicant shall not be required under paragraph 8 of...
s.sch003
In the case of— (a) an active ingredient not described...
s.sch003
Paragraph 1 of this Schedule shall not apply unless the...
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.