The 2015 Annual Report of the State Agency of Medicines

The State Agency of Medicines (SAM) has published its Annual Report of the year 2015 which summarizes information regarding the operation of the Agency during the previous year.

Svens Henkuzens, the Director of the State Agency of Medicines: “2015 has been a year filled with challenges for the State Agency of Medicines. Latvia assumed the responsibilities of the presiding member state of the Council of the European Union and the State Agency of Medicines organized seven events within the collaboration network of pharmaceutical regulatory authorities in Europe. The Latvian presidency was an opportunity to influence processes and priorities on the European Union agenda and to prove that the State Agency of Medicines is an equal partner within the collaboration network of European agencies.”

Public consultation on documents in the context of the new Clinical Trials Regulation

The State Agency of Medicines informs that the European Commission (EC) has released for public consultation documents in the context of the new Clinical Trials Regulation (EU) No. 536/2014. Stakeholders are invited to send their comments by 31 August 2016 via e-mail to: SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

Documents for public consultation:

1. “Risk proportionate approaches in clinical trials”
2. “Summary of Clinical Trial Results for Laypersons”
3. “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs)”)
4. “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”

Documents are available on the EC website.

From 16 June 2016 information regarding all MRP/DCP variations* with a positive outcome will be published on the website of the State Agency of Medicines

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that from 16 June 2016 information regarding all variations with a positive outcome for medicines authorised in mutual recognition and decentralised authorisation procedures (MRP/DCP), where Latvia is a Concerned Member State, will be published on the SAM website in the Section “Pakalpojumi → Humāno zāļu reģistrācija, pārreģistrācija un izmaiņas → Rīkojumi par zāļu reģistrāciju” (Izmaiņas Latvijas Zāļu reģistrā (ar paziņojumu) – pielikums Nr. 3-3) in Latvian. After publishing information regarding variations with a positive outcome on the SAM website submitters of variation applications will receive an informative e-mail (with the link to the SAM website).

Before this informing procedure was applied only to MRP/DCP variations with a positive outcome that were not related to amendments to the product information.

* excluding variations, which include time for the distribution of the remaining stocks of medicines, and variations which are related to the issue of an updated marketing authorization.

Information on shortages of medicines will be regularly published

Starting from 1 June 2016 the list of medicinal products that are permanently or temporarily not placed on the market of Latvia is being published on the website of the State Agency of Medicines (SAM).

The list contains information regarding the name of the medicinal product, package size, product No., strength, name of active substances, starting date of the disruption in the supply of the product and the estimated date for renewal of the supply, as well as information on alternative medicines.

The list is available in the “Register” section of the website. Read more

From 13 June 2016 all PSURs have to be submitted only to the PSUR Repository

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 13 June 2016, the European Medicines Agency (EMA) has adopted as a mandatory requirement to submit all PSURs only to the Repository. PSUR Repository supports both the PSUR Single Assessment Procedure as governed by the EURD list and the single, pure NAP procedures where the active substance is only authorised in one Member State. From that date PSURs can no longer be submitted to SAM.

If PSUR for the medicinal product authorised only in Latvia and will be evaluated at the national level is submitted to the Repository the marketing authorisation holders are recommended to use the EMA template table cover letter to accompany submission of purely national PSURs to the PSUR repository. For more details, please visit the EMA website.

Updated information on approval of educational materials and direct healthcare professional communication

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that on 27 May 2016 updated information on submission and approval of educational materials (EM) included in the risk management plan for medicines and direct healthcare professional communication (DHPC) was published on SAM website.

Important updates:

• A new single e-mail address em_dhpc@zva.gov.lv has been established for submission of both types of documents (EM and DHPC).
• Updated information regarding the approval procedure for EM and DHPC.
• Updated standard text that regards reporting of adverse drug reactions, including the SAM phone number in cases where it is necessary for a healthcare professional to contact SAM experts, and the supplementary text that should be added in case of biological medicinal products.
• The information regarding the EM content and format has been updated in accordance with the Guideline on Good Pharmacovigilance Practices, Module XVI, Addendum 1 "Educational Materials".
• In order to facilitate the preparation of documents for submission of EM SAM recommends that marketing authorisation holders (MAHs) use a checklist (Annex 1) indicating all documents that need to be submitted within EM approval procedure.

We invite the responsible MAHs’ persons, especially national level contact persons for pharmacovigilance issues, to use the updated information. This information is available on SAM website, section "Services > Pharmacovigilance > Information for marketing authorisation holders > Submission and approval of risk minimisation measures".

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that on 20 May 2016 from 5:30pm till 11pm the Public Drug Register of the Republic of Latvia will not be available due to the construction works. We apologize for the inconvenience!

Changes in office hours of the State Agency of Medicines

Please be informed that on 3 May 2016 the State Agency of Medicines (SAM) is open from 8:30 till 15:00. SAM Customer Service Center is open from 9:00 till 12:30.

• Thursday, 4 May - closed.

Medicinal product turnover in Latvia was 336 million euros in 2015

The total turnover of medicinal products in Latvia has constantly increased over the last couple of years. Since 2011 the annual turnover has been close to 300 million euros (including VAT) reaching 336 million euros in 2015 which consisted of the turnover of authorised medicinal products worth 332 million euros and turnover of unauthorised medicinal products worth four million euros. Those are the basic conclusions of the experts of the State Agency of Medicines upon processing the statistical data on consumption of medicines in 2015.

The turnover for Latvian medicines manufacturers in the local market has increased by approximately four million euros since 2011 reaching 16 million euros in 2015 and making up 4.7% of the total amount of medicines sold in Latvia. Meldonium containing medicines have had the highest sales figures in euros among Latvian medicines manufacturers, but the highest number of packages sold were for medicines manufactured in Latvia containing the following combination of active substances: paracetamol, acetylsalicylic acid and caffeine.

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More convenient way to receive State Agency of Medicines services

In order to ensure a faster and more qualitative circulation of electronic correspondence and payment documents, the State Agency of Medicines kindly asks its clients to submit confirmation regarding the ability to receive electronic documents (with a secure electronic signature) and payment documents (electronically prepared invoices that are valid without a signature or stamp; Comparison acts of reciprocal payments).

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Changes in office hours of the State Agency of Medicines

Please be informed that on 24 March 2016 the State Agency of Medicines (SAM) is open from 8:30 till 15:00. SAM Customer Service Center is open from 9:00 till 12:30.

• Friday, 25 March - closed;
• Monday, 28 March - closed.

The management of the State Agency of Medicines participates in the meeting of the European Medicines Agency’s Management Board

On 17 March 2016 Svens Henkuzens, the Director of the State Agency of Medicines, and Jānis Zvejnieks, the Deputy Director, are participating in the meeting of the European Medicines Agency’s  (EMA) Management Board in London.

The agenda of the meeting includes evaluation of EMA involvement in international projects such as Innovative Medicines Initiative aiming to speed up the development of better and safer medicines for patients, update on development of EU clinical trial portal and database, pharmacovigilance data collection, election of the Chair of the Management Board and other important issues.

On 18 March 2016 Svens Henkuzens and Jānis Zvejnieks have the bilateral meeting with Guido Rasi, the Executive Director of EMA, to discuss issues related to the availability of medicines on the market of Latvia.

Latvian manufacturers sold medicines and other products worth 132 million euros in 2015

According to the data gathered by the State Agency of Medicines (SAM) regarding operation of medicines manufacturers, the total turnover of the products of Latvian medicines manufacturers once again experienced a slight decrease in 2015. The total turnover of the manufactured products (medicines and other products) was 132 million euros (excluding VAT) and that is 2% less than in 2014. In 2015 the proportion of production sold in the local market increased by 4 percentage points and made up 14% of the total products manufactured. Thus, 86% of the manufactured products were exported. In comparison with 2014, last year the amount of medicines sold in Latvia increased by 32% and the amount of medicines sold abroad decreased by 4%.

Director of the State Agency of Medicines Svens Henkuzens, 'The contribution and presence of local medicines manufacturers is felt not only by every patient who has medicines manufactured in Latvia in their first aid kit at home, but also by the national economy. Even though the total production amount has slightly decreased in 2015, it still remains a great benefit for Latvia.' Read more

Implementation of the updates in line with the QRD template for medicinal products

Information for marketing authorisation holders

The European Medicines Agency’s Working Group on Quality Review of Documents revised the Quality Review of Documents (QRD) template for the product information for medicinal products (Summary of product characteristics, Patient information leaflet and labelling text) in April 2013.

The information regarding national reporting system of suspected adverse reactions for healthcare professionals and patients was added. Applicants were encouraged to implement the updates in line with the QRD template for medicinal products with regulatory activity until April 2015 and for medicinal products without regulatory activity until April 2016. Further information please see The Heads of Medicines Agencies website Q&A section (answers to Q 2.11.a and 2.11.b).

Latvian delegate participates in the Heads of Medicines Agencies meeting

On 17th and 18th February 2016 Svens Henkuzens, the Director of the State Agency of Medicines (SAM), is attending the scheduled Heads of Medicines Agencies (HMA) meeting in Amsterdam which is being organised by the Medicines Evaluation Board of the Netherlands as part of the Netherlands Presidency of the Council of the European Union (EU).

The meeting agenda contains several important issues related to the pharmaceutical field, including:

• Priorities of the Netherlands Presidency of the EU Council in the field of collaboration of pharmaceutical regulators – more rapid availability of new medicinal products (innovation) to patients; fighting the antimicrobial resistance, interruptions in the supply of medicines in Europe and solutions for prevention of such interruptions;
• Approval of the long-term work plans for HMA and EMA in accordance with the 2016 2020 operational strategy of both organisations.

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