Tag Archive for: Falsified medicines

Falsified Medical Directive (FMD) and updated QRD template released February 2016

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:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Falsified_Medicines/CMDh_345_2016_Rev00_02_2016_1.pdf

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:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

 

What do you need to do?:

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?

 New MAAs 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)

 Ongoing MAAs

  • 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).
    • If the ATD does not affect the container and its closure system, or is placed on the outer packaging, no regulatory procedure is necessary. However, if the addition of the ATD has an impact on the readability of the packaging information, MAHs are requested to submit mock-ups as per http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004891.pdf

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:

  1. UNIQUE IDENTIFIER – 2D BARCODE
  1. UNIQUE IDENTIFIER – HUMAN READABLE DATA

Updated QRD template in track changes is available here:

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/12/WC500029823.pdf

 

Are any medicinal products exempt from the above?

Yes, the medicinal products exempt from the above are listed in Annex I of the Regulation located here:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

 

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:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

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.

EF photo

HPRA Safety Features Workshop – update

Ivowen recently attended the HPRA Safety Features Workshop Athlone (3rd May 2016).  The following is a summary of the key take-home points from this workshop.

Introduction of a Unique Identifier (UI) and Anti-tampering Device (ATD) on Packaging of POM and Certain OTC Medicines

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on safety features (Commission Delegated Regulation (EU) 2016/161) may impact the product information of MAs.  The Delegated Regulation applies to medicinal products for human use and specifically prescription only medicines (POM) and certain non-prescription/over-the-counter/general-sale-list medicines (OTC/GSL).

  • All POMs are required to carry safety features, with the exception of radiopharmaceuticals and those products listed in Annex I of the Regulation (EU) No 2016/161 (“white list”)
  • Categories not subject to prescription; OTC/GSL medicines are not required to carry a safety feature unless they are listed in Annex II of the Regulation (EU) 2016/161 (“black list”). The black list includes documented evidence of falsification of medicines other than POMs e.g. omeprazole
  • The purpose of the safety features is to allow for the identification and authentication of human medicinal products
  • The safety feature including ATD must be placed on the outer packaging or in the case of no outer packaging on the immediate packaging (if the ATD affects the container closure system, then information on how the ATD affects the container closure system is required in section 3.2.P.2.4 and/or 3.2.P.7 of the MA dossier)

Products outside the scope of the Delegated Regulation include veterinary, investigational, and exempt medicinal products.  Additionally medicinal products manufactured in the EU and destined for export only are also exempt.

Composition of the Unique Identifier (UI)

Manufacturers will be required to encode the unique identifier in a 2-D barcode and to print data elements in human-readable format.

2-D Barcode

The 2-D barcode will consist of a sequence of numeric or alphanumeric characters.

  • Product Code: allowing identification of at least the Tradename, common name, the pharmaceutical form, the strength, the pack size and the pack type
  • Serial Number: a numeric or alphanumeric sequence of maximum 20 characters
  • Reimbursement Number: if required by the Member State
  • Batch Number
  • Expiry Date

Human-readable Format

In addition to the 2-D barcode manufactures will also be required to print the data elements in human-readable format so as to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.

Anti-tampering Device (ATD)

Manufacturers Choice of tamper evident seal.

The Regulation shall apply from 9th February 2019 where all relevant medicinal products placed on the market or QP certified will need to have the new safety features in place.  The safety features may be implemented in advance of this date provided the functioning repository is in place and the MA dossier has been updated to include reference to the safety feature.  MA holders are advised to update product information during the 3-year transition period and this can be done during any ongoing regulatory procedure (e.g. Renewal, Variation IA, IB, II, new or existing MAA application) – no additional fees; or alternatively submit an Article 61(3) Notification – usual fee will apply.

Further detailed guidance can be found under the following links:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

http://ec.europa.eu/health/files/falsified_medicines/qa_safetyfeature.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/02/WC500201413.pdf

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Falsified_Medicines/CMDh_345_2016_Rev0_February_2016.pdf

Ivowen can assist you in notifying competent authorities of the safety features and updating your MA dossier for new, on-going and existing MAAs.  Ivowen are also fully eCTD-ready and compliant. Please contact us for more information and for support of your application.

Written by Laura Oakey

Laura Oakey

HPRA update on Batch-specific requests for safety features

The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features.  This is an update on the Falsified Medicines Directive safety features information.
The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human use, came into force in Ireland on the 9th February 2019.

BSRs will be considered for medicines for the Irish market that come within the scope of the regulation but do not bear safety features (UI and ATD).

The article outlines the details the MAH must provide in the BSR application.
Furthermore, the MAH must confirm that safety features have already been registered with the HPRA and if not a simultaneous Article 61 (3) notification must be submitted with the BSR application. 

For full details on this issue the full article can be found here: https://www.hpra.ie/homepage/about-us/publications-forms/newsletters/item?id=55950b26-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/newsletters/hpra-medicinal-products-newsletter—issue-number-61

Written by:

Claire Brown