Commission Regulation (EC) No 1234/2008 Article 8

Notification procedure for minor variations of type IA

Article 8

1. Where a minor variation of type IA is made, the holder shall submit simultaneously to all relevant authorities a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following the implementation of the variation. However, the notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned. 2. Within 30 days following receipt of the notification, the measures provided for in Article 11 shall be taken.

Read the full instrument → · Read this in context: CHAPTER II — VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC →

Other provisions in CHAPTER II — VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 8 of Commission Regulation (EC) No 1234/2008 (LawPlayer, data as of 2026-07-04)

What to look at next

Commission Regulation (EC) No 1234/2008, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year CHAPTER II — VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC — read this in contextThe surrounding text of the act in order, so you can see what comes before and afterChapters and sections