- Latest available (Revised)
- Point in Time (31/01/2020)
- Original (As adopted by EU)
Commission Regulation (EC) No 1234/2008Show full title
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Revised version PDFs
- Revised 04/08/20130.77 MB
- Revised 02/11/20120.74 MB
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Changes over time for: Article 16
Version Superseded: 17/05/2024
Status:
Point in time view as at 31/01/2020. This version of this provision has been superseded.
Status
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
Changes to legislation:
There are currently no known outstanding effects by UK legislation for Commission Regulation (EC) No 1234/2008, Article 16.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Article 16U.K.‘Prior Approval’ procedure for major variations of type II
1.The holder shall submit to the Agency an application containing the elements listed in Annex IV.
If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application.
2.The Agency shall issue an opinion on the valid application referred to in paragraph 1 within 60 days following its receipt.
[F1The Agency may reduce the period referred to in the first subparagraph, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 7(2)(c).]
The period referred to in the first subparagraph shall be 90 days for variations listed in Part 2 of Annex V.
3.Within the period referred to in paragraph 2, the Agency may request the holder to provide supplementary information within a time limit set by the Agency. The procedure shall be suspended until such time as the supplementary information has been provided. In this case the Agency may extend the period referred to in paragraph 2.
4.Article 9(1) and (2) and Article 34(1) and (2) of Regulation (EC) No 726/2004 shall apply to the opinion on the valid application.
Within 15 days from the adoption of the final opinion on the valid application, the measures provided for in Article 17 shall be taken.
[F25. This Article shall not apply where a type II variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply.]
Textual Amendments
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Chapter
PrintThis Article only
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 adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
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 adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- 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.