Referrals procedures

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

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

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

Adopted Reference Number: SOP/H/3249 Summary:

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 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

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

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withdrawn or varied to restrict the indications or availability, amend the posology, add a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

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

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...

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