- Latest available (Revised)
- Original (As made)
The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993
You are here:
- UK Statutory Instruments
- 1993 No. 2538
- Table of contents
What Version
More Resources
Status:
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
5.Amendment of the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971
INFORMATION, DOCUMENTS, SAMPLES AND OTHER MATERIAL REQUIRED IN RESPECT OF APPLICATIONS
3.The qualitative and quantitative particulars of all the constituents of...
5.Particulars of the therapeutic indications, contra-indications and side-effects.
6.Particulars of the posology, pharmaceutical form, method and route of...
8.Subject to Schedule 2, particulars, drawn up and signed by...
9.A summary of the product characteristics which shall contain the...
10.A copy of the manufacturing authorisation as defined in Article...
11.A copy of any authorisation obtained in a member State...
12.An expert’s report (stating, where applicable, the grounds for using...
13.Brief information about the educational background, training and occupational experience...
14.One or more samples or mock-ups of the sales presentation,...
15.A statement of the number of volumes of documentation submitted...
17.Where the applicant is, by virtue of paragraph 8 above,...
18.Where the applicant is, by virtue of paragraph 8 above,...
19.A statement indicating— (a) which of the following should apply...
22.Where the applicant, in relation to all or any particular...
23.Where the licence applied for is required solely for the...
24.A statement indicating that the applicant agrees that the licence...
25.All other information which is relevant to the evaluation of...
1.Subject to paragraphs 2 to 4 below, the applicant shall...
2.Notwithstanding paragraph 1 above, the applicant shall provide particulars of...
3.Where the product is a new medicinal product containing known...
5.Subject to compliance with paragraphs 19(a) and 22 of Schedule...
6.The applicant shall not be required under paragraph 8 of...
Options/Help
Print Options
PrintTable of Contents
PrintThe Whole Instrument
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.