GUIDELINE : PACKAGING INFORMATION OF MEDICINAL PRODUCTS FOR HUMAN USE AUTHORISED BY THE UNION

Transcription

1 1 GUIDELINE : PACKAGING INFORMATION OF MEDICINAL PRODUCTS FOR HUMAN USE AUTHORISED BY THE UNION M2 ARIEPS - Sujet réglementaire 14/15 novembre 2016 Clotilde SAINT-PAUL

2 2 Guideline for medicinal products GUIDELINE ON THE PACKAGING INFORMATION OF MEDICINAL PRODUCTS FOR HUMAN USE AUTHORISED BY THE UNION = Regulatory guideline (Volume 2C) Mandatory

3 3 Guideline for medicinal products EudraLex collection of rules & regulations governing medicinal products in the EU 10 volumes Volume 2: pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use Volume 2A: procedures for marketing authorisation Volume 2B: presentation and content of the dossier Volume 2C: regulatory guideline

4 4 GUIDELINE EXPLANATIONS Legal farmework Purpose 3 sections: Labelling Package leaflet Presentation of the medicinal product Annex

5 5 Legal framework Regulation EC 726/2004: centralised Union procedure Directive 2001/83/EC on the Community code relating to medicinal products for human use Article 8 (3) (j) Title V: labelling and packaging leaflet ü Article 57 ü Article 62

6 6 Purpose Described how the above mentionned provisions apply in the case of a MA * to be granted by the Commission Provided information on the items required by some Member States (Article 57) on the additional items included in the labelling (Article 62) Assisted applicants when drawing up the labelling and package leaflet preparing the mock-up and specimens (sales presentation) * MA : Marketing Authorisation

7 7 Focus on Article 57 Member States may require to ascertain on labelling: price of the medicinal product reimbursement conditions of social security organisations legal status for supply to the patient authenticity and identification Article 62 Outer packaging and package leaflet: may include symbols or pictograms clarify certain information compatible with SmPC * useful to patient and exclusion of any element of a promotional nature * SmPC : Summary of Product Characteristics

8 8 Section labelling The text of the labelling Language Additional labelling information required by some MS * Legal status Marketing autorisation number Optional information under article 62 of the Directive Local representative Blind and partially-sighted patients Control of the conformity of the labelling with Directive Changes to the labelling * MS : Member States

9 9 Section package leaflet The text of the labelling Language Additional labelling information required by some MS Legal status Marketing autorisation number Optional information under article 62 of the Directive Local representative Blind and partially-sighted patients Control of the conformity of the labelling with Directive Changes to the labelling

10 10 Section presentation Pack sizes In accordance with the duration of treatment and posology in the SmPC But not in accordance with local traditions or prescription habits Pack design Logo, format layout, style, colour scheme and if possible the pack dimension should be identical throughout the Union Pack composition

11 11 Annex «Blue Box» Boxed area with blue border è Included in the labelling è Aimed specific information to each Member State ü Under article 57 ü Under article 62 European Union Member states + Norway + Iceland

12 12 è France Price - No requirement Reimbursement - No requirement Legal status Specific warnings required for: prescription-only products products subject to special prescription (narcotic) products subject to special restricted (to hospital use,...) Identification and authenticity Barcode rules (code CIP) Symbols or pictograms

13 13 Bibliography Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) Directive 2001/83/CE of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use index_en.htm

14 14 THANK YOU FOR YOUR ATTENTION Questions?