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Template issued by the European Commission for the qualified person’s declaration on GMP comlpiance Date: 14. January 2014 Topics: Licensing Type: News

A new Template issued by the European Commission for the qualified person’s declaration on GMP compliance

Can an adaptation of the texts to be in line with the current QRD templates be submitted together with Type 1A or Type IAIN variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

It is possible to submit an adaption of the texts together with Type IA or Type IAIN variations. This change is classified as a Type IB variation with the change category C.I.z. which is subject to fees. This classification is a grouping of a …

How is the adaption to the model texts published by the BfArM to be submitted? Date: 11. December 2013 Topics: Licensing Type: FAQ

Following the recommendation pursuant to Article 5 of the Variation Regulation, the adaption to the model texts should be classified as variation C.I z.

C.I.z Change(s) in the SmPC, labelling or package leaflet of human …

Can an implementation of the explanatory statements on additional monitoring and ADR reporting be submitted together with Type 1A or Type IAIN variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

It is possible to submit the implementation of the explanatory statements on additional monitoring and ADR reporting together with Type IA or Type IAIN variations. This change is classified as a Type IAIN variation with the change category C.I.z. in …

Under which classification category can adaptation of the texts (SmPC/PIL/labelling) to conform with the excipient guidelines be submitted as a national variation? Date: 11. December 2013 Topics: Licensing Type: FAQ

Adaptions of texts to conform with the excipient guidelines (changes in the SmPC and corresponding PIL/labelling) are to be submitted as variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to …

How should an update of the texts in line with the current QRD templates be submitted in the absence of any further changes to the product information? Date: 11. December 2013 Topics: Licensing Type: FAQ

If only the adaption of the texts in order to be in line with the current QRD template without any further changes (a single variation) is submitted, this is considered to be a Type IB variation with a change category C.I.z. for which fees will …

Under which classification category can adaptation of the texts (SmPC/PIL/labelling) to conform with the MedDRA terminology be submitted as a national variation? Date: 11. December 2013 Topics: Licensing Type: FAQ

Adaptions of texts to conform with the MedDRA terminology (changes in the SmPC and corresponding PIL/labelling) are to be submitted as a variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to …

How should the implementation of the explanatory statements on additional monitoring and adverse drug reaction (ADR) reporting be submitted in Type IB or Type II variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

If the implementation of the explanatory statements on additional monitoring and ADR reporting is submitted in addition to a Type IB or Type II variation of change category C, this should be stated clearly in the cover letter and under “Precise scope …

How should the implementation of the explanatory statements on additional monitoring and ADR reporting be submitted in the absence of any further changes to the product information? Date: 11. December 2013 Topics: Licensing Type: FAQ

If only the implementation of the explanatory statements on additional monitoring and ADR reporting without any further changes (a single variation) is submitted, this is considered to be a Type IAIN with variation a change category C.I.z. in …

How should an adaptation of texts in line with QRD templates be submitted in the context of Type 1B or Type II variations? Date: 11. December 2013 Topics: Licensing Type: FAQ

If an update of the texts in line with the QRD templates (labelling, PIL and SmPC) is submitted in addition to a Type IB or Type II variation, this should be stated clearly in the cover letter and under “Precise scope and background for change” in …