Referrals procedures

Standard operating procedure on Article 30 referrals triggered by the European Commission or a Member State

AdoptedReference Number: SOP/H/3215Legal effective date: 04/09/2012Summary:

To describe the procedure for handling of referral procedures according to Article 30 of Directive 2001/83/EC as amended triggered by the European Commission or a Member State for non-centrally authorised medicinal products for human use.

Standard operating procedure on Article 29 procedures according to the Paediatric Regulation No 1901/2006

AdoptedReference Number: SOP/H/3249Summary:

To describe the procedure for handling of procedures under Article 29 of the Paediatric Regulation No. 1901/2006 as amended for non-centrally authorised medicinal products for human use.

Standard operating procedure on Article 107 procedures - Pharmacovigilance urgent measures

AdoptedReference Number: SOP/H/3250Summary:

To describe the procedure for handling of procedures according to Article 107(2) of Directive 2001/83/EC as amended for non-centrally authorised medicinal products for human use.

Standard operating procedure for procedures in accordance with Article 78 of Directive 2001/82/EC, related to pharmacovigilance measures for veterinary medicinal products authorised in the European Union

AdoptedReference Number: SOP/V/4025Legal effective date: 11/02/2016Summary:

To describe the procedure following notification from a Member State in accordance with Article 78 (1)

of Directive 2001/82/EC where it considers that a marketing authorisation should be suspended,

withdrawn or varied to restrict the indications or availability, amend the posology, add a

contraindication or add a new precautionary measure as a result of evaluation of pharmacovigilance

data, where after the CVMP is to give its opinion on the matter in accordance with Article 78 (3) of

Directive 2001/82/EC.

Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures

AdoptedReference Number: SOP/H/3176Legal effective date: 25/09/2012

Standard operating procedure for Article 20 procedures

AdoptedReference Number: SOP/H/3192Legal effective date: 29/11/2010

Work Instructions for preparation of referral opinions for publication on the EMA website (Referrals according to Article 5(3), 5(11),6(12), 6(13), 13, 20, 29(4), 29 (paediatric), 30, 31, 36 and 107 for medicinal product...

AdoptedReference Number: WIN/H/3205Legal effective date: 28/10/2010

Standard operating procedure for referral procedures in accordance with the provisions of Articles 33(4), 34 and 35 of Directive 2001/82/EC, and Article 13 of Commission Regulation (EC) No 1234/2008, related to veterinar...

AdoptedReference Number: SOP/V/4024Legal effective date: 18/12/2015