Guideline on good pharmacovigilance practices (GVP) Annex II









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215562Guideline on good pharmacovigilance practices (GVP) Annex II

See websites for contact details

European Medicines Agency www.ema.europa.eu

Heads of Medicines Agencies www.hma.eu

The European Medicines Agency is

an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2015. Reproduction is authorised provided the source is acknowledged. 8

December 2015

EMA/334164/2015 Draft for public consultation Guideline on good pharmacovigilance practices (GVP) Annex II - Templates: Communication Plan for Direct Healthcare Professional

Communication (CP DHPC)

Draft finalised by the Agency in collaboration with Member States 17 November 2015 Draft agreed by European Risk Management Strategy Facilitation Group (ERMS FG)

24 November 2015

Draft adopted by Executive Director 8 December 2015

Start of public consultation

15 December 2015

End of consultation (deadline for comments)

29 February 2016

Date for coming into effect Q2 2016

Comments should be provided using this template. The completed comments form should be sent to gvp@ema.europa.eu. Guideline on good pharmacovigilance practices (GVP) - Annex II - DHPC CP EMA/334164/2015 Draft for public consultation Page 2/2

DHPC COMMUNICATION PLAN

Medicinal

product(s)/active substance(s)

Marketing

authorisation holder(s) In cases where the DHPC concerns several marketing authorisation holders of the same active substance or is part of a class review, it is strongly encouraged that a single consistent message is sent to healthcare professionals in each EU Member State. All concerned marketing authorisation holders in each Member State are strongly encouraged to collaborate, so that a single DHPC is prepared and circulated in each Member State. The letter circulated in each

Member State

should cover all active substance-containing products authorised in that Member State.

It is encouraged that the originator

marketing authorisation holder (where available) in each Member State acts as the contact point for the national competent authority, on behalf of the other concerned marketing authorisation holders in the same Member State. If no originator product is marketed in the Member State, it is encouraged that the concerned generic companies acts as contact point for the competent authority.

Safety concern and

purpose of the communication Consider using the title of the DHPC to describe the safety concern DHPC recipients List all recipients of the DHPC in this section, e.g. general practitioners, specialists, pharmacists, nurses, professional societies, national associations.

Member States where

the DHPC will be distributed Timetable Delete steps which are not applicable Date

DHPC and

communication plan (in English) agreed by PRAC

DHPC and communication plan

(in English) agreed by CHMP/CMDh

Submission of

translated DHPCs to the national competent authorities for review

Agreement of translations by

national competent authorities

See websites for contact details

European Medicines Agency www.ema.europa.eu

Heads of Medicines Agencies www.hma.eu

The European Medicines Agency is

an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2015. Reproduction is authorised provided the source is acknowledged. 8

December 2015

EMA/334164/2015 Draft for public consultation Guideline on good pharmacovigilance practices (GVP) Annex II - Templates: Communication Plan for Direct Healthcare Professional

Communication (CP DHPC)

Draft finalised by the Agency in collaboration with Member States 17 November 2015 Draft agreed by European Risk Management Strategy Facilitation Group (ERMS FG)

24 November 2015

Draft adopted by Executive Director 8 December 2015

Start of public consultation

15 December 2015

End of consultation (deadline for comments)

29 February 2016

Date for coming into effect Q2 2016

Comments should be provided using this template. The completed comments form should be sent to gvp@ema.europa.eu. Guideline on good pharmacovigilance practices (GVP) - Annex II - DHPC CP EMA/334164/2015 Draft for public consultation Page 2/2

DHPC COMMUNICATION PLAN

Medicinal

product(s)/active substance(s)

Marketing

authorisation holder(s) In cases where the DHPC concerns several marketing authorisation holders of the same active substance or is part of a class review, it is strongly encouraged that a single consistent message is sent to healthcare professionals in each EU Member State. All concerned marketing authorisation holders in each Member State are strongly encouraged to collaborate, so that a single DHPC is prepared and circulated in each Member State. The letter circulated in each

Member State

should cover all active substance-containing products authorised in that Member State.

It is encouraged that the originator

marketing authorisation holder (where available) in each Member State acts as the contact point for the national competent authority, on behalf of the other concerned marketing authorisation holders in the same Member State. If no originator product is marketed in the Member State, it is encouraged that the concerned generic companies acts as contact point for the competent authority.

Safety concern and

purpose of the communication Consider using the title of the DHPC to describe the safety concern DHPC recipients List all recipients of the DHPC in this section, e.g. general practitioners, specialists, pharmacists, nurses, professional societies, national associations.

Member States where

the DHPC will be distributed Timetable Delete steps which are not applicable Date

DHPC and

communication plan (in English) agreed by PRAC

DHPC and communication plan

(in English) agreed by CHMP/CMDh

Submission of

translated DHPCs to the national competent authorities for review

Agreement of translations by

national competent authorities
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