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Tuesday 24.04.2018 | Name days: Nameda, Visvaldis, Ritvaldis
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Straujuma does not support HM’s plans to reorganize State Agency of Medicines

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Baltic news, News from Latvia, BNN.LV, BNN-NEWS.COM, BNN-NEWS.RULatvian Prime Minister Laimdota Straujuma does not support Healthcare Ministry’s plans to take over certain functions of the State Agency for Medicines, including its licensing function.

Straujuma admits that she personally and Unity does not support the idea of allowing the ministry, a body responsible for creating policies, to take over licensing functions. «It is wrong to move functions from SAM to the ministry, which is an institution meant to create policies,» – said Straujuma.

She believes that if there are problems with licensing, it is necessary to look at regulations and how well they are filled in. It is unacceptable to mix the system by handing over licensing functions under political supervision.

There will be some discussions held on this topic. It is also necessary to wait for comments from members of the coalition, added Straujuma.

It is possible there could be changes added to the re-organization plan. It could be cancelled completely as well, said the PM.

The government knows of Healthcare Ministry’s proposed amendments. An inspection of SAM has uncovered that matters related to evaluation of pharmaceutical activities are handled by two institutions under HM – State Agency for Medicines and Heath Inspection.

With that, a certain problematic situation has surfaced in Latvia. Whenever SAM carries out an evaluation of some medicine’s compliance with regulations and uncovers problems, it informs the Health Inspection, which then carries out a repeated inspection on its own. If it finds the same problem, the inspection is then able to decide on taking further action, such as the application of administrative penalty. All this uses up valuable resources of the ministry and adds an additional layer of bureaucratic burden on entrepreneurs, as mentioned by HM specialists.

The plan provides for delegating SAM’s functions in regard to issuing permits for clinical trials of different medicines to Healthcare Ministry. It is also planned that the ministry will also take over the agency’s function to issue special permits (licenses) for beginning pharmaceutical activity.

Ref: 102.109.109.6792


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