The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here:
Summary of Main Changes:
The changes to Quality Review of Documents (QRD) templates are detailed in the updated guidance for the pharmaceutical industry. The main modifications are:
the acceptance of combined SmPCs for different strengths of the same pharmaceutical form whereas until now a separate SmPC was required for each strength of the same pharmaceutical form
the dates to be recorded in section 9 of the SmPC (i.e. date of first authorisation and date of latest renewal)
the text to be included in Annex II (for centrally approved products (CAPs) only)
the list of local representatives in the PL may only contain the address of the local representative of the marketing-authorisation holder (MAH) in the Member State where this particular medicine is sold, instead of the contact details of all local representatives in all EU Member States (for CAPs only)
What does this mean for you?
This means that updates to common sections can be managed in one document, instead of multiple documents making life-cycle management much easier and reducing variation preparation time, etc.
These dates only need to go in once, and the only one that will require updating is the renewal date. Since most products ordinarily undergo only one renewal, this date will also only have to be inserted once.
The standard text to be included pertaining to the submission of PSURs has changed. This needs to be updated at the next variation to the your approved QRD text.
This is really good news for all holders of Community Authorisations! (products approved through the Centralised Procedure). Instead of having to list up to 31 local contacts on the printed PIL, it is now permissible to list only the local contacts associated with that particular PIL. For example, for Ireland and UK dual packs, only the Irish and UK local contact need be listed. This will result in serious space savings on individual PILs, and time and efficiency improvements for regulatory affairs departments who need to keep the document life-cycles up to date.
What’s next?
Ivowen have extensive experience with the Centralised Procedure and QRD template changes and maintenance. Please contact us if you would like to discuss any of the above changes or any issues that you might have with your centrally approved products.
Ivowen would also advise that you take this opportunity to check over older approved QRD Annexes and correct any legacy typos, font issues, etc.
Written by Majella Ryan
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2015-07-03 11:04:022023-11-06 11:08:25EMA introduces changes to the QRD templates
Falsified medicines are fake medicines that are designed to mimic real medicines. Due to the increase of falsified medicines on the market the EU has a strong legal framework for licensing, manufacturing and distribution of medicines. In July 2011 DIRECTIVE 2011/62/EU (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF ) came into force; this directive aims to prevent falsified medicines entering the legal supply chain and thus reaching patients. One of the Directive’s measures is the introduction of safety features on medicines.
Update on Safety Features on Medicines:
On February 9th 2016 the EC published an implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use:
In conjunction, a Regulation was also published laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use:
The Delegated Regulation will apply in all European countries from the 9th February 2019 (3 years after its publication). Belgium, Greece and Italy have the option of deferring the application of the rules by an additional period of up to 6 years.
There are two safety features to be placed on the packaging of most prescription medicines and certain non-prescription medicines no later than 9 February 2019.
-1). a unique identifier (a 2-dimension barcode) and
-2). an anti-tampering device (ATD).
How does this affect your medicinal products and applications?
NewMAAs submitted from April 2016:
QRD:
Revised QRD template.
Revised dossier sections:
In the case of medicinal products where the ATD is placed on the immediate packaging because there is no outer packaging and the ATD affects the container and its closure system(s), applicants are required to include information on the ATD and how the ATD affects the container and its closure system(s) (sections 3.2.P.2.4 and/or 3.2.P.7 of the Notice to Applicants Volume 2B)
OngoingMAAs
QRD:
CHMP opinion in March 2016 advised to comply Revised QRD template
CHMP opinion from April 2016 onwards, applicants must comply with the revised QRD template
Revised dossier sections:
As per new MAAs
Existing MAs
QRD:
Revised QRD template within 3 years – Can be implemented in Type IA, Type IB, Type II, Renewals, Line extension etc. where the submission affects the product information (PI). Approval of submissions must be no later than the 9th February 2019. If no regulatory procedure occurs within the required timeframe a notification is requested to be submitted pursuant to article 61(3).
Revised dossier sections:
If the ATD is placed on the immediate packaging and the ATD affects the container and its closure system(s), applicants are required to submit the appropriate variations to include the information on the ATD and how the ATD affects the container and its closure system(s) (see section B.II.e of the Variation Guidelines).
Medicinal product no longer needs to bear safety features
QRD:
Regulatory procedure to remove the standard statements regarding the unique identifier and ATD.
Revised dossier sections:
ATD on immediate packaging: Regulatory procedure to remove the statements regarding the ATD in the dossier. ATD on outer packaging – no regulatory procedure necessary.
Change of Legal Status
QRD:
Non-prescription to prescription following a MAH switch application: MAH should use the regulatory procedure to comply with the revised QRD and regulations. Non-prescription to prescription following a Commission referral or a PSUR assessment, the Commission Decision will cover, inter alia, the regulatory requirements to implement the safety features.
Revised dossier sections:
Non-prescription to prescription: MAH should use the regulatory procedure to include the information on the ATD and how the ATD affects the container and its closure system(s)
What does the new QRD template now include?
The new QRD template includes the following sections in: Particulars to appear on <the outer packaging> <and> <the Immediate packaging:
UNIQUE IDENTIFIER – 2D BARCODE
UNIQUE IDENTIFIER – HUMAN READABLE DATA
Updated QRD template in track changes is available here:
Are any medicinal products not subject to prescription but that should include the safety features above?
Yes, the medicinal products not subject to prescription that shall bear the safety features, referred to in Article 45(2) are listed in Annex II of the Regulation located here:
If you have any queries on the above, if you would like any help with complying with the new regulation or if you have any other queries please contact us .
Written by Emily Fletcher.
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2016-03-14 12:47:332023-11-06 11:08:27Falsified Medical Directive (FMD) and updated QRD template released February 2016
