Spring Intro 2023

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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Leaflet requirements (1/4)

1. What is X and what is it used for ?

- Indications - Pharmacotherapeutic group (how it works)

2. What you need to know before you take (use) X

- Do not take (use X): absolute contraindications - Warnings and precautions: information and action to minimise risk - Other medicines and X (also food, drink, and alcohol) - Pregnancy, breastfeeding, and fertility - Driving and using machines - X contains: information about excipients

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