European Medicines Agency publishes 2012 annual report

The report highlights the main trends recently observed in the Agency’s activities. For the past few years, the Agency has received a stable number of initial marketing-authorisation applications (MAAs) for human medicines, with a total of 96 applications received in 2012. The Committee for Medicinal Products for Human Use (CHMP) issued 59 positive opinions for the approval of new medicines, including a positive opinion for the first gene therapy in Europe.
The European Medicines Agency 2012 annual report is available here.

Submission of Educational Materials for the risk minimization to the State Agency of Medicines

Taking into account, that the 22nd January 2013 Cabinet of Ministers Regulation No. 47 "Procedure for Pharmacovigilance" has come into force, the State Agency of Medicines has updated the description, published on 31st March 2010, of procedure for submitting educational materials stated in the risk minimisation plan to the State Agency of Medicines. The updated description is available here.

Dear clients!

Information regarding the annual post-authorisation maintenance fee for medicines

The State Agency of Medicines (hereinafter - SAM) would like to point out that in accordance with Article 85 of the 9th May 2006 Cabinet of Ministers Regulation No. 376 "Procedure for the Registration of Medicinal Products" the expenditures of post-authorisation maintenance of medicines shall be covered by the marketing authorisation holder. Article 85.6 of the Regulation No. 376 states that the annual post-authorisation maintenance fee for medicines shall be applied in the next calendar year following the marketing authorisation or renewal of medicinal product.

Basing on an application submitted by the marketing authorisation holder SAM has the right to adopt a decision regarding exemption from the annual post-authorisation maintenance fee, if all of the following requirements have been fulfilled during the previous calendar year:

1) the price of medicines has been declared in SAM in accordance with the normative acts regarding determination of the price of medicinal products;
2) the medicines are distributed in Latvia, but the turnover during the previous calendar year does not exceed 1500 Ls;
3) in accordance with the requirements of normative acts regarding procedure for distribution of medicinal products, the marketing authorisation holder has reported to SAM the actual date of beginning of distribution (marketing) of medicines in Latvia or has reported the medicines withdrawn from the market of medicines in Latvia (temporarily or permanently).

We remind you that the marketing authorisation holder has the right to submit the application for exemption from the annual post-authorisation maintenance fee during the entire year whether all the three of aforementioned requirements have been fulfilled. Please note that the application for exemption from the annual post-authorisation maintenance fee for medicines can be submitted regardless whether or not the marketing authorisation holder has received the appropriate invoice from SAM.

Dear clients!

Submission of the electronic documentation in the non-eCTD (NeeS) format

The State Agency of Medicines (hereinafter SAMLV) informs you that starting from March 18, 2013 there will be launched documentation in NeeS format uploading into SAMs database. In order to ensure positive technical validation, please take into consideration guidance for NeeS submissions for human medicinal products in the EU. Note, if technical validation is negative, you will be informed about invalidation issues via email during 5 days; if technical validation is positive – email will not be sent. Guidance for NeeS you can see here. For more information please visit EMA home page (PDF file). Read more.

The State Agency of Medicines publicly available paid service pricelist has been approved

On 14th February 2013 the Cabinet of Ministers Regulation No. 75 “The State Agency of Medicines Publicly Available Paid Service Pricelist” of 29th January 2013 (hereinafter - Regulation) came into force determining the paid services provided by the State Agency of Medicines (hereinafter - Agency) and the payment procedure.

The Regulation determines the procedure of making payment for the additional services provided by the State Agency of Medicines.

To encourage marketing authorisation holders to enter the market of medicinal products in Latvia by authorising new medicines the Regulation entails decreased prices for the following services regarding marketing authorisation of medicines:

• expertise on application and additional documentation for marketing authorisation of medicines in the national procedure for the first submitted dosage form
  • with a new active substance - 60%;
  • with a known active substance, fixed combination (new medicines containing at least two active substances where the combination has not been previously authorised as a fixed combination medicinal product), similar biological medicinal products or medicines with well-established medicinal use - 25%;
• expertise on application and additional documentation for marketing authorisation renewal in the national procedure for single dosage form - price decrease by 25%; for each additional dosage form - 20%;
• expertise on a periodic safety update report of nationally authorised medicines for medicines containing the same active substance or the same active substances for one marketing authorisation holder - 70%.

Several new paid service positions have been introduced in the Regulation that include review of application for approval of the site (address) of pharmaceutical activity submitted by the merchant, evaluation of compliance of the site for use of tissues, cells, organs and dead human bodies for implementation of medical studies program in a higher education institution, issuing of permit (certificate) duplicate for the corresponding health care institution or higher education institution, as well as issuing of the electronic edition of the official Drug Register of the Republic of Latvia containing summary of product characteristics and package leaflets of medicines. The Regulation also specifies paid service positions and prices regarding change of legal address of the merchant or change of the address of the pharmaceutical activity company, changes in the special permit (licence) for pharmaceutical activity (including expiration date) and its annexes, if evaluation of compliance of the pharmaceutical activity company is not necessary, as well as regarding costs of the official edition of the Drug Register of the Republic of Latvia.

The new Regulation replaces the 17th January 2006 Cabinet of Ministers Regulation No. 61 “Regulation Regarding the State Agency of Medicines Publicly Available Paid Service Pricelist”.

The full text of the 29th January 2013 Cabinet of Ministers Regulation No. 75 “The State Agency of Medicines Publicly Available Paid Service Pricelist” is available here (PDF file).

Pharmacovigilance regulation „Procedure for Pharmacovigilance” comes into force on 1st Ferbuary 2013

The State Agency of Medicines (hereinafter - SAM) informs, that from 1st February of 2013 Cabinet of Ministers Regulation No. 47 „Procedure for Pharmacovigilance” comes into force. New regulation determines the procedure for pharmacovigilance for medicinal products intended for human use. Unofficial translations in English is available here.

State Agency of Medicines of Latvia receives two UKAS accredited certifications

Director of SAM shows the received acknowledgement.
Photo: SAM.

The New Year celebration for employees of the State Agency of Medicines of Latvia (hereafter SAMLV) has been laurelled with the United Kingdom Accreditation Service accredited certification.

SAMLV is a state institution under the supervision of the Ministry of Health of the Republic of Latvia that carries out evaluation, marketing authorisation, monitoring, control and regulation of distribution of medicines and medical devices in Latvia according to the requirements of international standards ISO 9001:2008 (quality management systems) and ISO/IEC 27001:2005 (information security management system).
Read more

Dear clients!

The State Agency of Medicines informs that starting from 2nd January 2013 SAM will have a new payment account.

The requisites of the State Agency of Medicines are as follows:

State Agency of Medicines

Jersikas street 15, Riga, LV-1003
VAT reg. No. LV90001836181
Riga settlement center of the Treasury
LV24TREL9290579005000
BIC TRELLV 22

Numbering of variations for medicinal products that were authorized via national procedure

Please be informed that according to COMISSION REGULATION (EU) No.712/2012 of August, 2012, amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (hereinafter – Regulation), starting from January 1st, 2013, must begin numbering for variations for medicinal products that were authorized via national procedure.

In accordance with chapter IIa from Regulation, paragraph 13b and 13c, there will be validation for type IB and II variations starting from August 3rd, 2013. Validation phase will provide verification for documentation submitted for variations in national procedures. To number the variations in national procedures, please use the version used for Mutual recognition and Decentralised Registration procedures (info: CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure - Chapter 1 CMDh Best Practice Guide for the allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II variations, Grouping and Worksharing; Doc. Ref.: CMDh/094/2003/Rev18, November 2012), including marketing authorisation No., type of variation and relevant serial number (E.g. 00-0000/IA/ 001, 00-0000/IB/002/G; 00-0000/II/003).

The actual variation procedure number will be given in decision for variations acceptance or non-acceptance as well as in notice of validation.

Dear Clients!


Foto: The HMA The State Agency of Medicines (hereinafter - SAM) informs, that the Heads of Medicines Agencies, which is a network of then Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the EEA, has published survey about the HMA website.

The HMA is working on optimising its web presence and thus would like to get a better idea about clients information needs. In the questionnaire the HMA would appreciate client’s suggestions for improvement e.g. regarding quality, content and usability.

Proceed to Survey

Dear Clients!

In accordance with amendments to the Law "On Value Added Tax" the VAT was reduced to 21%. Please note that in the „State Agency of Medicines publicly available paid service pricelist” was amended several changes. Changes are available here.

Dear Clients!

The State Agency of Medicines (hereinafter - SAM) informs that the invoice regarding annual fee for postmarketing surveillance is sent to the marketing authorisation holder (MAH). Please note that upon making the payment the invoice number must be indicated in the payment document. If several payments are made regarding one invoice, then this invoice number must be indicated in all the payment orders.

The total sum of an invoice shall not be divided into separate invoices (payment makers) and the invoices will not be reissued unless there is legal justification for reduction of the invoice sum.

SAM would like to remind that the marketing authorisation holder is responsible for making payments in a timely manner and to full extent and that in case of unfulfilled financial commitments a decision can be made regarding withdrawal of medicines from the Drug Register.

Reminder for marketing authorisation holders regarding information to be included in the labelling of traditional herbal medicinal products

According to the Article 21 of the 17.01.2006. Cabinet of Ministers Regulation No. 57 “Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for Package Leaflets of Medicinal Products” the labelling and package leaflet of the traditional herbal medicinal products (herbal medicinal products that comply with the criteria specified in the normative acts on marketing authorization procedures for medicinal products and are authorized in a simplified procedure) shall contain the following particulars: (1) a statement that the specific product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-term use; (2) a statement that the user should consult his/her physician or a qualified health care specialist, if symptoms remain during the administration of the medicinal product or some adverse reactions develop that are not mentioned in the package leaflet; (3) a statement on the traditional use of the herbal medicinal product.

We would like to draw your attention to the fact that according to Article 37 of the above mentioned Regulation the requirements laid down by the Article 21 of these Regulations shall be applied till October 30, 2012 for traditional herbal medicinal products already marketed before these Regulations shall come into force.

Attention clients!

In accordance with Article 8 of the Official Language Law the State Agency of Medicines as a state institution shall use the official language in correspondence with clients. Correspondence and other kinds of communication with foreign states may take place in a foreign language.

We inform you that starting with July 1st 2012 letters of authorisation in a foreign language shall be submitted together with a translation in the official language. On the last page of the translation under the text the interpreter places a verification inscription in the official language to verify the accuracy of the translation. The verification inscription consists of the words “TULKOJUMS PAREIZS” written in capital letters; the name, last name and personal identity number of the interpreter; the signature of the interpreter; the name of the place of verification; date of verification.
Authorisation Letter Sample (.doc format)

ATTENTION! Information regarding submission of product information in Latvian for type IA and IB variations for medicines authorised in mutual recognition (MRP) and decentralised procedures (DCP).

We inform you that in accordance with the requirements of CMDh Best Practice Guides for Submission and Processing of Variations in the Mutual Recognition Procedure translations of product information (summary of product characteristics, package leaflet and labeling) in Latvian should be submitted at the same time with the application form. If the translation is not submitted or is submitted late, the appropriate variation application will be invalidated.

Please send the translations of product information to the State Agency of Medicines e-mail Translations_mrp-dcp@zva.gov.lv indicating the precise and correct variation procedure number.