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The Human Medicines Regulations 2012

The Human Medicines Regulations 2012

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Published by: Fuzzy_Wood_Person on Jul 30, 2012
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02/26/2013

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STATUTORY INSTRUMENTS
2012 No. 1916MEDICINES
The Human MedicinesRegulations 2012
Made
 
-
 
-
 
-
 
-
 
19th July 2012 Laid before Parliament 
 
24th July 2012Coming into force
 
-
 
-
 
14th August 2012
£38.00
 
STATUTORY INSTRUMENTS
2012 No. 1916MEDICINES
The Human Medicines Regulations 2012
Made
 
-
 
-
 
-
 
-
 
19th July 2012 Laid before Parliament 
 
24th July 2012Coming into force
 
-
 
-
 
14th August 2012
CONTENTS
PART 1
General
1. Citation and commencement 142. Medicinal products 143. Scope of these Regulations: special provisions 154. Special provisions for pharmacies etc 165. Classification of medicinal products 176. The licensing authority and the Ministers 187. Advertisements relating to medicinal products 188. General interpretation 19
PART 2
Administration
9. Commission on Human Medicines 3010. Functions of the Commission 3011. British Pharmacopoeia Commission 3012. Reporting to Ministers 3113. Co-option of additional members of advisory bodies 3114. Appointment of expert advisory groups 3115. Delegation of functions to expert advisory groups 3116. Further provision about advisory bodies and expert advisory groups etc 32
PART 3
Manufacturing and wholesale dealing
Grant etc of licences
17. Manufacturing of medicinal products 3218. Wholesale dealing in medicinal products 3219. Exemptions from requirement for wholesale dealer’s licence 33
 
220. Mixing of medicines 3421. Application for manufacturer’s or wholesale dealer’s licence 3422. Factors relevant to determination of application for manufacturer’s or wholesaledealer’s licence 3423. Grant or refusal of licence 3524. Standard provisions of licences 3525. Duration of licence 3526. General power to suspend, revoke or vary licences 3627. Procedure where licensing authority proposes to suspend, revoke or vary licence 3628. Suspension of licence in cases of urgency 3729. Variation of licence on the application of the holder 3730. Provision of information 38
Miscellaneous and offences
31. Certification of manufacturer’s licence 3932. Sale and supply of starting materials 3933. Offence concerning data for advanced therapy medicinal products 4034. Offences: breach of regulations and false information and defence concerningstarting materials 4035. Penalties 40
Conditions for holding a manufacturer’s licence
36. Conditions for manufacturer’s licence 4137. Manufacturing and assembly 4138. Imports from states other than EEA States 4139. Further requirements for manufacturer’s licence 4240. Obligation to provide information relating to control methods 4241. Requirements as to qualified persons 42
Conditions for holding a wholesale dealer’s licence
42. Conditions for wholesale dealer’s licence 4343. Obligations of licence holder 4344. Requirement for wholesale dealers to deal only with specified persons 4545. Requirement as to responsible persons 45
PART 4
Requirement for authorisation
46. Requirement for authorisation 4647. Breach of requirement 47
PART 5
Marketing authorisations
48. Application of this Part 48
 Application for UK marketing authorisation
49. Application for grant of UK marketing authorisation 4850. Accompanying material 4851. Applications relating to generic medicinal products 4952. Applications relating to certain medicinal products that do not qualify as genericetc 4953. Applications relating to similar biological medicinal products 5054. Applications relating to products in well-established medicinal use 50

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