On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EMA Updates Product Information Templates for Medicinal Products for Human Use
In the EU, certain elements of product information are required as part of the marketing authorisation requirements and post authorisation measures for medicinal products for human use. This includes information contained in the Summary of Product Characteristics (SmPC), the Labelling and Package Leaflet.
Summary of Product Characteristics
According to the revised QRD template, the use of combined SmPCs for different strengths of the same pharmaceutical form could be permitted where the SmPCs are identical. If, however, the therapeutic indications are different for the different strengths the applicant could present the SmPCs in a single document for the evaluation process only. The applicant will subsequently be required to provide a separate SmPC for each strength and pharmaceutical form containing all pack-sizes.
Annex I Section 9 to the revised QRD template for centralised procedures defines the dates that must be recorded by MAHs. As such, the following points must be observed:
i) The date of the initial marketing authorisation of the medicinal product must reflect the initial date of the Commission Decision regarding the marketing authorisation; and
ii) The date of the (conditional) renewal of the concerned medicinal product must reflect the actual date of the Commission Decision.
With regard to the preparation of radiopharmaceuticals, Annex I Section 12 highlights that a link to the competent authority of the relevant EU Member State is optional and must only be displayed on the final printed materials. Subsequently, it will not be necessary to provide the link in the Product Information Annexes.
Obligations of the Marketing Authorisation Holder
Annex IIC to the revised QRD template provides new statements with regard to periodic safety update reporting. The MAH must choose either the European birth date or international birth date of the medicinal product. The selected birth date will constitute the basis of the data lock point for the first period update report (“PSUR”).
In accordance with Annex IID to the revised QRD template, the MAH must state whether the post-authorisation measure is a post-authorisation efficacy study (“PAES”) or non-interventional post-authorisation safety study (“PASS”).
Labelling and Package Leaflet
Annex III to the revised QRD template provides guidance on the provision of quick response (“QR”) codes. If the QR code is included in the packaging material and/or the Package Leaflet, the choice of location must ensure readability. Reference to the QR code must be detailed in Annex IIIA and/or Annex IIIB as “QR to be included” and followed by the corresponding URL. This reference will be designated in accordance with the information provided.
Annex IIIB Section 6 to the revised QRD template provides that the printed Package Leaflet must contain the sole contact details of the local representative of the marketing authorisation holder in the relevant EU Member State where the medicinal product is sold. Previously, this information was required for all local representatives. Nevertheless, there still remains an obligation to provide the full list of local representatives in the Product Information Annexes.
Timeframe for Implementation of revised QRD Template
In a separate guidance document the EMA outlines the implementation plan for the revised QRD template concerning centralised procedures. The guidance provides the following instructions:
(i) With regard to on-going marketing authorisation applications, the revised QRD template must be implemented as soon as possible. The final date for complying with the changes must be Day 181 of the marketing authorisation procedure;
(ii) Applicants who submit a new marketing authorisation application after 10 June 2015 must respect the revised QRD template immediately. If, however, a new marketing authorisation application is due to be submitted within two (2) months from the date of publication of the revised QRD template, this requirement will not apply. Applicants will be required to comply with the revised QRD template at a later date (Day 121) of the marketing authorisation procedure; and
(iii) Current MAHs are recommended to update their Product Information Annexes at the first available opportunity. This could be achieved when an application for a line extension or variation to the existing marketing authorisation is submitted. Alternatively, MAHs will be required comply with the revised QRD template on the date of the renewal of the marketing authorisation. If, however, such opportunities do not arise, MAHs must recognise the changes reflected in the QRD template within 3 years from the date of the publication of the revised QRD template.
Applicants and MAHs are recommended to consult with their respective Procedure Manager in view of the discussed changes introduced by the QRD template and the timeframe for compliance.
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