EMA Implementation Working Group with EU Pharmaceutical Industry Associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) 726/2004 Agenda item 4.1 Draft proposal - Notifications of the location of the Presented by: Ilaria Del Seppia Data Collection and Management Section 5 December 2012 An agency of the European Union
In accordance with the Commission s implementing regulation, chapter I, Article 4, paragraph 4 and without prejudice to the requirements set out in Regulation (EC) No 1234/2008, the marketing authorisation holders shall notify immediately the Agency of any change in the location of the pharmacovigilance system master file (PSMF). A change in the location of the PSMF should be notified by the marketing authorisation holder to the Agency within 30 calendar days from the date when the change becomes effective (closure of the variation procedure see presentation agenda item 6). 1
For the use of the applicable operation type, please refer to presentation for agenda item 6. 2
Pharmacovigilance System Master File Location EVCODE (PSMFL EVCODE) Scenarios 1 2 3 4 5 6 7* a. Different global company (HQ) b. Same global company (HQ) and different affiliates a. Different global company (HQ) b. Same global company (HQ) and different affiliates MAH Same Different Different Same Different Different Same Different Same Location Same Same Same Same Same Same Different Different Different PV SYSTEM Same Same Same Different Different Different Different Different Same EVCODE to request 1 >1 1 >1 >1 >1 >1 >1 1 COMMENT FIELD List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE List internal PV SYSTEM CODE Handling of Location Scenarios * Only applicable to variation affecting the location of the PSMF whilst the MAH and the PV System remain the same. 3
Handling of Location Scenarios 4
The PSMF definition is provided in Article 1(28e) of Directive 5 2001/83/EC and the minimum requirements for its content and maintenance are set out in the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. The detailed requirements provided by the Commission Implementing Regulation are further supported by the guidance in Module II of the Good Vigilance Practice(s) (GVP). The PSMF shall be located either at the site in the EU where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the EU where the qualified person responsible for pharmacovigilance operates [IM Art 7(1)].
At the time of marketing authorisation application, the applicant should submit electronically the PSMF location information using the agreed format as referred to in chapter IV, Article 26, paragraph 1(a) of the Commission Implementing Regulation (EU) No 520/2012, and subsequently include in the application, the PSMF reference number, which is the unique code assigned by the Eudravigilance (EV) system to the master file when the XEVPRM is processed. On grant of a marketing authorisation application, the PSMF will be linked by the marketing authorisation holder to the EVMPD product code(s). 6
To request an EVCODE for a PSMF, the following three characteristics need to be taken into account: i. The marketing authorization holder (MAH) as a legal entity ii. The location of the PSMF iii. The Pharmacovigilance System (PS) The following case scenarios provide explanations, as to when and how a EVCODE for a PSMF needs to be requested: 7
Scenario 1: MAH A has a PSMF location D for the PV system X and therefore requests one EVCODE. The internal code for PV system X should be specified in the comments field (MF 11) by MAH A for the medicinal products applicable. 8
Scenario 2a: MAH A and MAH B are different legal entities belonging to different global companies. MAH A and B share the same PV system Y at the same location R. Both MAH A and MAH B request a separate EVCODE. The internal code for PV system Y should be specified in the comments field (MF 11) by the MAH A and by MAH B for the medicinal products applicable. 9
Scenario 2b: MAH A and MAH B are different legal entities belonging to the same global company. MAH A and B share the same PV system Y at the same location R. Both MAH A and MAH B share the same EVCODE. The internal code for PV system Y should be specified in the comments field (MF 11) by the MAH A and by MAH B for the medicinal products applicable. 10
Scenario 3: MAH A has two different PV systems Y and Z, each with a separate PSMF in the same location R. MAH A therefore requests a separate EVCODE for the PV System Y and corresponding PSMF at location R and for the PV System Z and corresponding PSMF at location R. The internal code for PV systems Y and Z should be specified in the comments field (MF 11) by the MAH A for the medicinal products applicable. 11
Scenario 4a: MAH A and MAH B are different legal entities belonging to different global companies. MAH A and B have different PV systems Y and Z at the same location R. Both MAH A and MAH B request a separate EVCODE. The internal code for PV system Y should be specified in the comments field (MF 11) by MAH A and for PV system Z by MAH B for the medicinal products applicable. 12
Scenario 4b: MAH A and MAH B are different legal entities belonging to the same global company. MAH A and B have different PV systems Y and Z at the same location R. Both MAH A and MAH B request a separate EVCODE. The internal code for PV system Y should be specified in the comments field (MF 11) by MAH A and for PV system Z by MAH B for the medicinal products applicable. 13
Scenario 5: MAH A has two different PV systems Y and Z, each with a separate PSMF in two locations R and S. MAH A therefore requests a separate EVCODE for the PV System Y and corresponding PSMF at location R and for the PV System Z and corresponding PSMF at location S. The internal code for PV system Y and Z should be specified in the comments field (MF 11) by MAH B for the two corresponding EVCODEs. 14
Scenario 6: MAH A has a PSMF at location D for one PV system X; MAH B has a PSMF at location E for one PV system Z. Therefore MAH A and MAH B each request a separate EVCODE. The internal code for PV system X should be specified in the comments field for the EVCODE by MAH A. The internal code for PV system Z should be specified in the comments field by MAH B. The internal code for PV system X should be specified in the comments field (MF 11) by MAH A. The internal code for PV system Z should be specified in the comments field (MF 11) by MAH B. 15
Scenario 7: Only applicable to variation affecting the location of the PSMF whilst the MAH and the PV System remain the same. In this scenario the PSMF location should be updated to reflect the change in the location but the PSMF EVCode shall be maintained. Submission of the summary of the pharmacovigilance system information to competent authorities to fulfil the requirement of Article 8(3) of the Directive 2001/83/EC (and within XEVMPD), cannot contain multiple locations for a single pharmacovigilance system master file (PSMF). The PSMF location declared should be an office address which reflects either the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or the site in the Union where the qualified person responsible for pharmacovigilance operates. 16 [References: Commission implementing regulation No 520/2012, Article 7 (1), Directive 2001/83/EU, Article *(3), GVP Module II (II.B.3)]
Scenario 7: Only applicable to variation affecting the location of the PSMF whilst the MAH and the PV System remain the same. In this scenario the PSMF location should be updated to reflect the change in the location but the PSMF EVCode shall be maintained. MAH A has a PSMF at location D for one PV system X; MAH A change only the location of the PV system X from location D to location Z. MAH A should submit an XEVPRM with operation type Update of the relevant PSMFL EVCode with the change of the location from D to Z. 17
Please refer also to the Question and Answers on transitional arrangements concerning the entering into force of the New Pharmacovigilance Rules provided by Directive 2010/84/EU amending Directive 2001/83/EC and Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 as well as the Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation. 18
Discussion 19