CRED SMPC 2024

Implementation of requirements in the UK

National legislation:

The Human Medicines Regulations 2012 number 1916 [SI 2012/1916]. Set out in chapter 13 and schedules 24, 25, 26 and 27

EU legislation (with respect to Northern Ireland):

Directive 2001/83/EC (amended by 2004/27/EC)

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National and EU legislation

Requirement/procedure

EU legislation

UK legislation

Human Medicine Regulations 2012 [SI 2012/1916]

Directive 2001/83/EC

Submission of labelling and/or PIL for assessment

Article 61.3

Regulation 267

Leaflet content (general)

Article 59.1

Schedule 27

Leaflet content (paracetamol)

National requirement

Schedule 25 (Part 4)

User testing

Article 59.3

Regulation 260 (3)

Labelling requirements (general)

Article 54

Schedule 24 (Part 1)

Labelling requirements (paracetamol)

National requirement

Schedule 25 (part 4)

Labelling (blister)

Article 55.2

Schedule 24 (Part 2)

Labelling (small container)

Article 55.3

Schedule 24 (Part3)

Braille/provisions for blind and partially sighted patients

Article 56 (a)

Regulation 259

Extra statutory information

Article 62

Regulation 261

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