Medicines for human use

Guidance for clinical trials, manufacturing, licensing, selling and advertising of medicines for human use

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Medicines for animal use

Guidance for manufacturing and licensing of medicines for animal use

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Scientific animal protection

Educational resources for applying the 3R principle (Replacement, Reduction and Refinement) in animal research

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Medical devices

Guidance for complying with the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR)

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Cosmetics

Guidance for complying with the requirements for making, importing and selling cosmetic products

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Blood

Licensing and inspections of blood establishments

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Tissues and cells

Licensing and inspections of tissue establishments

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Organs

Inspections and regulations related to organs for transplantation.

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Controlled drugs

Licences and registration for controlled drugs.

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Precursor chemicals

Licencing and registration of operators, movement of precursor chemicals, and duties of a responsible officer.

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Classification and innovation

Classify borderline health products and receive support for developing new health products

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Critical Entities Resilience

Organisations formally designated as critical entities will have specific obligations under CER legislation.

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Manufacturing of medicines

Guidance documents

Guidance documents provide information about complying with regulatory procedures.

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Guidance documents