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Guidance for Marketing Authorisation Holders and holders of other types of authorisations on their responsibilities for veterinary pharmacovigilance and how to report suspected Adverse Events.
Application form ADV2: register as a person to be notified of an application for adverse possession.
Application form ADV1: registration of a person in adverse possession.
Explainer for the pharmaceutical industry on Pharmacovigilance requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR).
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Advises on how planning can manage potential noise impacts in new development.
Form NAP: notice to the registrar in respect of an adverse possession application.
Form ST1: Statement of truth in support of an application for registration based upon adverse possession.
Guidance on managing and using bed rails safely.
Reviews existing evidence of the risks posed by adverse weather to different populations. Also outlines next steps to improve understanding of these risks.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Information for public health professionals on immunisation.
Organisational definitions of terms concerned with risk and risk-related matters.
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