Lapkričio 10 dieną Rygoje įvyko trijų Baltijos šalių vaistinius preparatus kontroliuojančių tarnybų susitikimas, kurį suorganizavo Latvijos valstybinė vaistų kontrolės agentūra. Lietuvos ir Estijos atstovai pasveikino latvių kolegas su agentūros įkūrimo dešimtmečiu, pristatė savo šalies agentūrų struktūrą, veiklą, veiklos ypatumus, kartu aptarė visoms Baltijos šalims aktualius vaistinių preparatų registracijos, perregistracijos, farmakologinio budrumo, vaistų reklamos klausimus, susipažino su Latvijos specialistų sukurta informacine sistema (žr. bendrą trijų Baltijos šalių susitikimo protokolą anglų k.).
10 November 2006 MINUTES The Baltic Meeting took place on 10 November Objectives of this meeting were the discussion about the most rational procedures in implementation of some EU legislation requirements, further development of the cooperation, exchange of information, and the discussion about the possibilities of mutual consultation between the experts. In the beginning of the meeting the overviews about the basic functions, financing and structure of all three agencies were presented. Subsequently the work was organized in the groups of interests. As everybody wished to see the new Information System of the SAM Latvia (ZVAIS) it was presented to all of the participants. Discussions took place in following working groups:
The results of discussions and some conclusions were summarized in the closing meeting: 1. Baltic labelling The common guideline is in force and used quite widely by the companies. A problem for companies is the case when the 3 agencies are not following the guidelines or are interpreting it differently. Several practical examples were looked at and common solutions decided. It was agreed that specialists from 3 agencies would communicate via e-mails more closely to avoid the misunderstandings for the companies. 2. Pharmacovigilance a. Co-operation on PSURs The agencies will work out possible solutions taking into account the developments in the EU network on work sharing on PSURs, look at the possibilities to keep the issues in the same cycle. The agencies agreed that for medicinal products authorised in b. Risk management plans The responsibility of a physician to follow the SPC’s and especially some actions coming from risk management plans was discussed. The task of agencies is to ensure the availability of all the safety information and take an active part in informing the professional society and patients. 3. Import from 3rd countries Some overview was given and some practical questions were raised. The involvement of GMP specialists was discussed. 4. Co-operation between the labs of 3 agencies The idea was warmly welcomed and it was decided that the heads of the labs and chief specialists will meet within 1-2 months and start elaborating the possible directions and practical solutions of this co-operation. 5. Medicines advertising control Systems of three countries were described. Currently the practices are rather different and so is the practical experience. 6. Clinical trials Colleagues from Latvia and Estonia discussed level of harmonization and compliance with Directive of local legislation, existing procedure of authorisation of clinical trials, recruitment of experts from outside, clinical trial fees, qualification of investigators, trial centres (tendency of decentralization), work of Ethic committees, GCP inspections, SOPs related to clinical trials. Practical questions regarding concrete projects were raised. Further need for close co-operation between Baltic drug regulatory agencies was positively confirmed.
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www.emedicina.lt svetainė skirta tik sveikatos priežiūros ir farmacijos specialistams. www.emedicina.lt Lietuvos Respublikos sveikatos apsaugos ministro įsakymu 2021 m. spalio 21 d. Nr. V-2383 įrašyta į svetainių, kuriose gali būti reklamuojami receptiniai vaistiniai preparatai, sąrašą. Prieigą prie svetainės specialistai gauna patvirtinę savo profesinę kvalifikaciją. Naudingos nuorodos: Vaistų ir medicinos pagalbos priemonių kainų paieška, VVKT tinklalapis, Sveikatos priežiūros ar farmacijos specialisto pranešimo apie įtariamą nepageidaujamą reakciją forma, Interneto svetainės, kuriose gali būti reklamuojami receptiniai vaistiniai preparatai, Informacija apie vaistinius preparatus. Klausimus ir komentarus reklamos davėjui galite siųsti: redakcija@emedicina.lt, pastebėjimus dėl reklamos galite teikti: vvkt@vvkt.lt. Svetainės tvarkytojas: UAB “Farmacijos namai", Adresas: Karaliaus Mindaugo pr. 7, LT-44280 Kaunas, Telefonas: 8 (37) 22 10 49. Paskutinė svetainės peržiūros data: 2023/05/12
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