SIDC Guidance on the Processing of Type IA and IB Notifications
Obsah
SIDC Guidance on the Processing of Type IA and IB Notifications
Information for Marketing Authorisation Holders
To ensure a full compliance with the valid legislation the State Institute for Drug Control changes the Guidance for processing of type IA and IB variations from 1 October 2007 as follows:
Guidance on Type IA Notification:
An applicant submits to the State Institute:
a) 4 originals of a Notification Form (formerly 3 were required),
b) all required documents including those amended as a result of this notification.
State Institute acknowledges the receipt of notification by stamping [1] one of the Notification Forms at a submission (sending by mail is also acceptable, in this case State Institute will send a stamped Notification Form to the applicant).
If a notification is compliant with the conditions set out in the Commission Regulation [2], State Institute will make a confirmation on the validity of the notification within 14 days from the receipt by stamping [3] the Notification Form which will be forwarded to the applicant by the coordinator/assistant without any delay.
In a case of consequential revision of the marketing authorisation decision including enclosures (note: this means any update/change in SmPC, PIL and Labelling) State Institute will make a confirmation on the validity of the notification and respective enclosures will be attached.
This guidance is valid for national marketing authorisations and also for common European procedures (MRP/DCP) in a case that the Slovak Republic acts as a reference member state.
If the Slovak Republic acts in a common European procedures (MRP/DCP) as a concerned member state, State Institute will make a confirmation on validity of the notification and respective annexes will be attached only in a case of consequential revision of the marketing authorisation decision including annexes (note: this means any update/change in SmPC, PIL and Labelling.
Guidance on Type IB Notification:
An applicant submits to the State Institute:
a) 4 originals of a Notification Form (formerly 3 were required),
b) all required documents including those which will be changed and/or added within the notification concerned.
State Institute acknowledges the receipt of notification by stamping [1] one of the Notification Forms at a submission (sending by mail is also acceptable, in this case State Institute will send a stamped Notification Form to the applicant).
If a notification is compliant with the conditions set out in the Commission Regulation [2], State Institute will make a confirmation on the receipt of the valid notification within 5 days from the receipt by stamping [4] the notification form which will be forwarded to the applicant and the procedure shall start.
If a notification is not compliant with the conditions set out in the Commission Regulation [2], State Institute will refuse the submission without any delay and a non-acceptance grounds will be stated.
If State Institute will not sent any statement to the applicant within 30 days from the day of receipt a variation is considered as accepted.
In a case of consequential revision of the marketing authorisation decision including enclosures (note: this means any update/change in SmPC, PIL and Labelling) State Institute will make a confirmation on the receipt of the valid notification and respective annexes will be attached.
This guidance is valid for national marketing authorisations and also for common European procedures (MRP/DCP) in a case that the Slovak Republic acts as a reference member state.
If State Institute is of the opinion that a notification is not acceptable State Institute will proceed in compliance with paragraphs 8 - 11 of Article 5 EC Regulation.
[1] Text on stamp: Štátny ústav pre kontrolu liečiv, Kvetná 11, 825 08 Bratislava 26, dňa: dd.mm.rrrr (translation: State Institute for Drug Control, Kvetná 11, 825 08 Bratislava 26, date: dd.mm.rrrr)
[2] EC Regulation (ES) 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State;
[3] Text on stamp: Štátny ústav potvrdzuje platnosť oznámenia, dňa: dd.mm.rrrr; (translation :State Institute confirms the validity of the notification, date: dd.mm.rrrr);
[4] Text on stamp: Štátny ústav potvrdzuje doručenie platného oznámenia, dňa: dd.mm.rrrr (translation: State Institute confirms the receipt of the valid notification, date: dd.mm.rrrr)
[5] Notice to Applicants, VOLUME 2A, Procedures for marketing authorisation, CHAPTER 5;
Act 140/1998 Z. z. on medicinal products and medical devices as amended;
Act71/1967 Z. z. on administrative procedure as amended.