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June 19, 2015  


 

Implementation of Clinical Trials Regulation discussed at the meeting in Riga

On 16-17 June 2015 the meeting of the Heads of Medicines Agencies (HMA) Clinical Trials Facilitation Group (CTFG) took place in Riga. The main focus was on the implementation of the Regulation (EU) No 536/2004 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use which came into force in June 2014 and will be applied no sooner than 28 May 2016.

Clinical research is a very important and mandatory step in the process of developing new medicines. It is necessary to obtain data regarding the effectiveness and safety of these medicines. A harmonised approach ensures unified principles in the evaluation of applications for clinical trials throughout Europe and a competent benefit/risk assessment. Read more

 

June 18, 2015  


 

Changes in office hours of the State Agency of Medicines

Please be informed that according to the Regulation of the Cabinet No 245 from May 26 of 2014 “On postponement of working days in 2015” the working day – Monday, June 22, 2015 – has been postponed to Saturday, June 27, 2015.

Therefore working hours of the State Agency of Medicines are as follow:

  • Monday, June 22, closed;
  • Saturday, June 27, opened – working hours 8:30 – 15:00;
  • Reception Hours on Saturday, June 27 – 9:00 – 12:30.

Please be informed also that June 23 and June 24 are National Holidays in Latvia.

 

June 16, 2015  


 

Communication professionals of medicines agencies discuss introduction of common logo for internet pharmacies in EU starting from 1 July 2015

On 11-12 June, the meeting of the Heads of Medicines Agencies (HMA) Working Group of Communication Professionals (WGCP) took place in Jūrmala. One of the most important issues on the agenda was the introduction of a common logo for all pharmacies that allow residents to purchase medicines online starting from 1 July 2015.

The introduction of a common logo is laid down by the Directive of the European Parliament and of the EU Council relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, and the Commission Implementing Regulation on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity.

Read more

 

June 10, 2015  


 

From 1 July 2015 a contact person for pharmacovigilance issues at national level is required

The State Agency of Medicines (SAM) reminds marketing authorisation holders that amendments to the Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Pharmacovigilance" adopted on 22 January 2013 came into force on 4 October 2014 laying down the requirement for nomination of a contact person for pharmacovigilance issues at national level starting from 1 July 2015. The national level contact person needs to reside and work in Latvia. Read more

 

June 5, 2015  


 

Application of uniform quality management principles in European medicines agencies emphasized in Riga meeting

On 2-3 June 2015 the meeting of the Heads of Medicines Agencies (HMA) Working Group of Quality Managers (WGQM) took place in Riga, Latvia. The agenda of the meeting included implementation and ensuring of the uniform quality management principles in European medicines agencies.

Read more

 

May 26, 2015  


 

Dear Clients,

The State Agency of Medicines (SAM) of Latvia kindly informs that today from 22:00 till 3:00 tomorrow the SAM webpage will not be available due to the construction works. We apologize for the inconvenience!

 

May 19, 2015  


 

Competent Authorities for Medical Devices meeting in Riga

During the 36th Competent Authorities for Medical Devices (CAMD) meeting in February 2015 in Riga under the Latvian Presidency of the Council of the European Union the agenda focused on further developments building upon the achievements of the Joint Plan for Immediate Actions that arose out of the PIP Breast Implant scandal.

In addition to reviewing the successful role out of the notified body joint assessment programme and confirming progress to finesse that activity in light of experience, the attendees learned about the development of databases in Latvia, Estonia and Turkey which are designed to enhance market surveillance capabilities. Read more

 

May 14, 2015  


 

The 2015 Drug Register of the Republic of Latvia has been issued

The State Agency of Medicines (hereinafter - SAM) has prepared electronic and printed versions of the Drug Register of the Republic of Latvia that will be useful for physicians and pharmacists, as it contains thorough and objective information regarding medicines registered in the Republic of Latvia.

The SAM specialists have prepared a printed version of the Drug Register of the Republic of Latvia containing information regarding a total of 6776 medicines authorised in the national, mutual recognition, decentralised, centralised procedures, as well as parallel imported medicines. This issue contains trade names of medicines, pharmaceutical forms, international nonproprietary names (INN) of actives substances, strength/concentration, pharmacotherapeutic group, Anatomical Therapeutic Chemical (ATC) classification code, authorisation number, issuance procedure and marketing authorisation holders. Read more

 

May 13, 2015  


 

Lawyers and marketing authorisation experts of European medicines agencies discuss current pharmaceutical issues in Riga

On 6-7 May the meeting of the European Medicines Agencies Group on the Cooperation on Legal and Legislative Issues (EMACOLEX) took place in Riga. This informal working party provides legal advice within the European medicines regulatory framework and the network of regulatory authorities. The informal meeting of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) also took place with an aim to discuss issues related to the marketing authorisation of medicines in two or more EU Member States via mutual recognition or decentralised procedures. The meeting in Riga brought together almost 100 participants – leading marketing authorisation experts and lawyers from medicines agencies in the EU Member States and EEA countries. Read more

 

May 11, 2015  


 

Medicines turnover in Latvia increases every year

When evaluating the data regarding medicines consumption in 2014, the State Agency of Medicines (SAM) has concluded that the turnover for medicines has continuously increased during the previous years. Since 2010 the average annual turnover of medicines authorised in Latvia has been approximately 300 million euro (including VAT), reaching 316 million euro in 2014. The number of licensed medicines wholesalers has also increased reaching 73 wholesalers operating in Latvia in 2014.

Read more

 

April 29, 2015  


 

State Agency of Medicines accepts electronically signed documents from Latvia and other countries

Please pay attention that the State Agency of Medicines accepts electronically signed documents from Latvia and other countries. SAM accepts documents signed with secure electronic signatures from other countries, if the authenticity of the signature can be verified. A description (instruction, link to a website) should be provided together with the documents on how to open the document and how to verify the security of the electronic signature. More information about e-submission.

 

April 20, 2015  


 

Regarding application of annual pharmacovigilance fee

Compliance with pharmacovigilance requirements is a mandatory condition for all marketing authorisation holders in accordance with EU legislative acts. In accordance with the Section 10, Article 18 of the Pharmaceutical Law the State Agency of Medicines (hereinafter - the Agency) performs the functions of pharmacovigilance, including supervision of the adverse effects caused by the use of medicinal products, as well as creates and maintains a database in relation to supervision of safe use of medicinal products. By ensuring the aforementioned functions the Agency streamlines the requirements laid down for supervision of the safety of medicinal products, as well as establishes a team of competitive experts to ensure these tasks, therefore, a paid service has been established for the performance of pharmacovigilance related functions - an annual pharmacovigilance fee for medicinal products authorised through the national procedure (including mutual recognition and decentralised procedure). The annual pharmacovigilance fee includes.. Read more

 

 

April 17, 2015  


 

State Agency of Medicines reminds about the safe use of medicines

Rational use of medicines is based on the prescription of the accurate dosage of medicines in the pharmaceutical form most appropriate for the patient at the right time, providing also precise information about the instructions for use of medicines and warning about possible adverse reactions. The State Agency of Medicines invites the public to use medicines in accordance with the recommendations of the doctor or pharmacist, as well as the instructions provided in the package information leaflet. If suspicions of adverse drug reactions arise in association with the use of medicines, we invite you to report this to the State Agency of Medicines by filling out the Patient Report Form, as well consult your doctor to receive further recommendations.

In 2014 the State Agency of Medicines received a total of 290 adverse drug reaction reports. The main reporters in Latvia were doctors. Total number of adverse drug reaction reports (2001-2014).

Read more

 

April 2, 2015  


 

Dear Clients!

The State Agency of Medicines (SAM) of Latvia kindly informs that from April 3rd to April 6th the Information System of SAM, including the Public Drug Register of the Republic of Latvia may not be available due to the construction works. We apologize for the inconvenience!

 

March 27, 2015  


 

Market value of products made by national manufacturers decreased by 9% in 2014

The data collected by the State Agency of Medicines (hereinafter - SAM) regarding operating results of medicines manufacturers indicate a decrease in the total turnover of the products of Latvian medicines manufacturers in 2014. The total value of manufactured products (medicines and other products) sold was 135 million Euros (without VAT), which was decreased by 9% in comparison with 2013. The majority of the manufactured products (90%) were exported, but 10% of the manufactured products were sold in the local market. Read more

 

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@ZVALatvija
Š.g. maijā samazinājās zāļu realizācijas apgrozījums Latvijā. Vairāk lasiet: http://t.co/fyQoc4BgG5
vakar, 10:44
Izpēte liecina par zāļu papildu riska mazināšanas pasākumu materiālu noderīgumu veselības aprūpes speciālistiem:http://t.co/WtFkxKXYgE
3.07.2015 17:19
RT @VP_Latvijai: @farmacijaMIC Šī tiešām ir aktualizējama problēma. Pacienti par blaknēm var ziņot arī ZVA mājas lapā http://t.co/tNcBqdDyHj
3.07.2015 10:35





Last changes made on 06.07.2015.