Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 Jun... (32023R1182)
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (Text with EEA relevance)
- REGULATION (EU) 2023/1182 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 14 June 2023
- on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC
- (Text with EEA relevance)
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- Article 3
- Specific rules for medicinal products as referred to in Article 1(1)
- Article 4
- Specific rules for medicinal products as referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004
- Article 5
- Specific rules for the labelling of medicinal products as referred to in Article 1(1)
- Article 6
- Monitoring of medicinal products as referred to in Article 1(1)
- Article 7
- Prohibition against the movement to or placing on the market in a Member State of medicinal products as referred to in Article 1(1)
- Article 8
- Written guarantees provided by the United Kingdom to the Commission
- Article 9
- Suspension of the specific rules laid down in Articles 3, 4 and 5
- Article 10
- Exercise of the delegation
- Article 11
- Urgency procedure
- Article 12
- Transitional provisions for safeguard requirements
- Article 13
- Amendment to Directive 2001/83/EC
- Article 14
- Entry into force and application
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