Moji razgovori s Emom, šesti dio: Falsified medicines
Dear Mr Sinčić,
Further to your phone conversation with my colleague Hilde yesterday, I wanted to follow up with further background information on the role of EMA in the implementation of the falsified medicines directive, which you can find at the following link: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview
More information on the relevant supervising and enforcement authorities for falsified medicines in Croatia is available on the website of the Croatian Medicines Agency (HALMED):
https://www.halmed.hr/Promet-proizvodnja-i-inspekcija/Krivotvoreni-lijekovi/
(Google translation from Croatian – extract from the link above)
In order to combat counterfeit medicines, cooperation between customs, police, the Ministry of Health and HALMED has been established in Croatia, in which contact persons are defined, and intensive exchange of information is carried out in accordance with the competences. HALMED provides expert information regarding the classification and identification of products and directs to further competent treatment, and in certain cases carries out a quality check of the product/medicinal product under suspicion.
Supervision of drug traffic is carried out by the Pharmaceutical Inspection of the Ministry of Health. In case of finding a suspicious product in traffic, the procedure begins, and the police are involved in the investigation as appropriate.
The Medicines and Relevant Regulations Act clearly stresses that all legal and natural persons who carry out wholesale and retail traffic on medicinal products, as well as manufacturers of medicinal products, must immediately inform HALMED of a counterfeit medicinal product they receive or have been offered or are suspected of a counterfeit medicinal product.
I hope this helps. Please do not hesitate to let us know if you have any further questions.
Kind regards
Riccardo Mezzasalma
Institutional Liaison Officer
Institutional and Policy (AF-IP) Department
13 January 2022 10:51
Estemeed Mr. Mezzasalma,
Thank you very much for your e-mail and clarifications.
Indeed, I am aware of the existing EU surveillance and control framework for medical products according to the previous EMA answers to my questions. This includes those of the HALMED (Croatia) supervising and enforcement authority for falsified medicines.
However, these are only partially relevant to my original question.
The point of my question, and I kindly ask you a direct response, is on the authority in charge for assessment of the content and integrity of each products’ batch pursuant the EMA conditional marketing authorisation (specifically the currently approved ‘COVID-19 vaccines’). I am interested in the same authority in charge for pursuant face masks that are sold on the EU market within the frame of face mandatory usage imposed by majority of EU member states.
In particular:
1.Who is exactly in charge of controlling the real content and integrity of each batch of these two product categories sold in EU member states? This questions particularly aims to collect exact information on the authority that is in charge to perform regular experimental analyses and continuous quality control and content through batch analyses.
2.Who is exactly in charge for evaluation of specific potential health risks that might occur due to the usage of authorized products in applications that are not declared or guaranteed by the producers within the documentation submitted for marketing approval. This question is particularly relevant in the frame of mandatory policies in place for COVID-19 vaccines and face masks.
3.Are the EU member states national agencies, i.e. HALMED in Croatia, only an ‘expositure’ of the EMA and may act only according to the procedures and approved documentation relevant for authorization of certain products provided by EMA?
I appreciate your kind clarification on these points.
My sincere regards,
Ivan Vilibor Sinčić
24 January 2022 10:44
Dear Mr Sinčić
Thank you for your clarifications and additional questions. We are looking into them and will reply shortly.
In the meantime could you please clarify what you exactly mean with your third question? Are the EU member states national agencies, i.e. HALMED in Croatia, only an ‘expositure’ of the EMA and may act only according to the procedures and approved documentation relevant for authorization of certain products provided by EMA?
I am not sure I understand correctly what you mean by “expositure” and what is requested in the second part of the question and would be grateful for any further clarification.
Kind regards
Riccardo
1/25/2022 2:06 PM
Greetings,
By saying expositure I meant agency that works under same rules as EMA and cannot work otherwise.
Thank you.
1/25/2022 2:39 PM
Estemeed Mr. Mezzasalma,
Thank you very much for your e-mail and clarifications.
Indeed, I am aware of the existing EU surveillance and control framework for medical products according to the previous EMA answers to my questions. This includes those of the HALMED (Croatia) supervising and enforcement authority for falsified medicines.
However, these are only partially relevant to my original question.
The point of my question, and I kindly ask you a direct response, is on the authority in charge for assessment of the content and integrity of each products’ batch pursuant the EMA conditional marketing authorisation (specifically the currently approved ‘COVID-19 vaccines’). I am interested in the same authority in charge for pursuant face masks that are sold on the EU market within the frame of face mandatory usage imposed by majority of EU member states.
In particular:
1. Who is exactely in charge of controlling the real content and integrity of each batch of these two product categories sold in EU member states? This questions particularly aims to collect exact information on the authority that is in charge to perform regular experimental analyses and continuous quality control and content through batch analyses.
The authorities responsible for performing independent control of each vaccine lot are the Official Medicines Control Laboratories (OMCLs) from the EU/EEA who are part of the Official Control Authority Batch Release (OCABR) Network. All OMCLs performing OCABR test according to the approved testing guidelines and procedures that are agreed upon and adopted by all EU/EEA Member States and operate under a verified quality system following the standard ISO/IEC 17025. The results are thus recognised equally by all Member States.
Multiple OMCLs within the network carry out OCABR testing for COVID-19 vaccines to ensure a reliable supply of approved vaccines.
In addition to above, we would also like to refer to our previous reply to you on 24 November 2021 (also attached), specifically to our replies 1 and 3 thereof, where we stated the following:
Once a vaccine has received approval, batches can only be marketed and released following quality control testing if the product is in line with the specifications that were approved as part of the respective Marketing Authorisation. This control is carried out by the manufacturer. EMA does not carry out its own analysis. However, for most centrally authorised vaccines EU legislation requires that a Member State’s Official Medicines Control Laboratory performs an additional independent control for each batch before it is put on the EU market. This independent control is referred to as Official Control Authority Batch Release (OCABR[1]) and includes testing of agreed quality parameters and a compliance check of the manufacturer’s own test results.
As explained in question 1, once a COVID-19 vaccine has received approval, batches can only be marketed and released following quality control testing by the manufacturer as well as following Official Control Authority Batch Release (OCABR) by a Member State official medicines control laboratory. More information about the OCABR process for the authorised COVID-19 vaccines can be obtained from the EDQM which coordinates this process: https://www.edqm.eu/en/contact-edqm
You can contact the European Directorate for the Quality of Medicines of the Council of Europe for more up to date information on the OCABR network, as this is not managed by the EMA.
2. Who is exactly in charge for evaluation of specific potential health risks that might occur due to the usage of authorized products in applications that are not declared or guaranteed by the producers within the documentation submitted for marketing approval. This question is particularly relevant in the frame of mandatory policies in place for COVID-19 vaccines and face masks.
When a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation. e.g. in an unapproved indication or in an unapproved age group, dosage, or route of administration this practice is also known as “off label use”. Marketing authorisation holders (MAHs) are responsible, as part of their pharmacovigilance obligations, to provide to medicines authorities information related to the off-label use of medicinal products if associated with the occurrence of suspected adverse reactions. Member States may also put in place additional specific requirements at national level regarding the collection and submission by marketing authorisation holders of information on the off-label use of their products.
For COVID-19 vaccines, the competent authority to assess the safety reports related to off label use is also EMA as part of the European pharmacovigilance system. For COVID-19 products, as for all other medicinal products, the requirements for reporting side effects from off label use are defined in GVP VI.C.2.2.12. Reporting of off-label use. For more background on how this control is performed, we refer you again to the EMA webpage on Safety of COVID-19 vaccines.
3. Are the EU member states national agencies, i.e. HALMED in Croatia, only an ‘expositure’ of the EMA and may act only according to the procedures and approved documentation relevant for authorization of certain products provided by EMA?
Yes, Member States’ national agencies, such as HALMED in Croatia, work under the same rules as EMA, as they are also subject to same EU legislation for pharmaceuticals, in particular Regulation EC 726/2004 and EU Directive 2001/83, as transposed in national legislation. As regards centrally authorised products, such as the COVID-19 vaccines, MSs contribute to and benefit from the assessments on the quality, safety and efficacy of medicinal products performed jointly at the central level via the EMA scientific committees which consist of members nominated by each MS. The outcome of these assessments result in the EU marketing authorisation which sets out the approved conditions for use for the medicine concerned.
I appreciate your kind clarification on these points.
My sincere regards,
Ivan Vilibor Sinčić
2/9/2022 10:45 AM
Dear Mr Sinčić,
Thank you again for contacting the EMA. Please find below in blue our answers and clarifications.
As you might be aware, the EMA is not responsible for medical devices, therefore we are not competent to advise on the parts related to face masks in your questions below.
Should you have further questions, do not hesitate to let us know.
Kind regards
Riccardo
2/9/2022 10:45 AM
