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WebVeterinary Medicinal Products Unit fees for 2024 included in revised Veterinary Medicinal Products Regulations 2022. 04-12-2023 | 14:00. With effect from 1 January 2024, the …

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The Board Medicines Evaluation Board

WebThe Medicines Evaluation Board (MEB) is an independent administrative body within central government, which falls under the responsibility of the Ministry of Health, Welfare and …

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New reporting process for the Medicine Shortages and Defects

WebWith effect from 1 January 2022, the Medicines Evaluation Board and the Health and Youth Care Inspectorate will be introducing changes in the procedure for submitting …

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The Agency Medicines Evaluation Board

WebThe Medicines Evaluation Board Agency (MEB) is responsible for preparing and implementing decisions by the Board and for pharmacovigilance in the Netherlands. It …

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Cooperation in the Netherlands Medicines Evaluation Board

WebLareb collects and analyses reports of suspected adverse reactions passed on by healthcare providers, patients, and marketing authorisation holders. If necessary, the …

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GMP and quality defects Medicines Evaluation Board

WebGMP and quality defects | Medicines Evaluation Board. Good Manufacturing Practice (GMP) is a quality assurance system for the pharmaceutical industry. The quality of a medicinal …

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About MEB Human Medicines Evaluation Board

Web12-04-2023 | 11:00. The Medicines Evaluation Board publishes its 2022 annual report today. We look on the year the Covid pandemic petered out. This

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Manufacturing (F) (GMP) Medicines Evaluation Board

WebWhen applying for a licence for the manufacture of a veterinary medicinal product, the Veterinary Medicinal Products Unit (BD) processes this application. Subsequently, …

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Novel foods Medicines Evaluation Board

WebThe Novel Foods Unit of the Medicines Evaluation Board (MEB) advises the Ministry of Health, Welfare and Sport (VWS) on novel foods. An application for market authorisation …

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Mutual recognition procedure Application procedures

WebThe mutual recognition procedure is a European procedure. This is based on the principle of recognition of the assessment made by the Reference Member State (RMS). All …

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Reporting adverse events Medicines Evaluation Board

WebReports suspected to be related to the medicinal product (as assessed by the primary reporter or by the applicant/authorisation holder) must be sent to EudraVigilance. For …

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Marketing authorisation medicines for human use

WebA marketing authorisation has a limited period of validity when first granted. After 5 years, the MEB must decide based on a benefit-risk assessment if this authorisation can be …

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Conclusion of report: paracetamol is safe to use News item

WebPatients and consumers can continue to use paracetamol safely in the Netherlands. This is the conclusion of the Netherlands medicines authority MEB and the …

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National contact person for pharmacovigilance

WebThe MEB and the Health and Youth Care Inspectorate (IGJ) have compiled guidelines for a national contact person. This person: Should have a thorough command of both spoken …

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Decentralised procedure Medicines Evaluation Board

WebThe decentralised procedure should be used to obtain a marketing authorisation in several Member States when the applicant does not yet have a marketing authorisation in any …

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MEB advises to put AstraZeneca vaccination temporarily on hold

WebThe Medicines Evaluation Board (MEB) has advised Minister De Jonge of Health, Welfare and Sport (VWS) to consider to put the vaccination campaign with the …

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Mutual recognition procedure Medicines Evaluation Board

WebThe mutual recognition procedure is a European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State (RMS). The …

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Compassionate use programme Medicines Evaluation Board

WebThe compassionate use programme is intended for a group of patients (cohort). The medicinal product is currently in a clinical trial or a marketing authorisation has been …

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