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Regulation 174 provides an exemption to the requirement for authorisation of Regulation 46 (requirement for authorisation to sell), allowing for the sale or supply of any medicinal product to be temporarily authorised by the licensing authority (MHRA) in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.
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A regulation, is directly applicable in Member States after its entry into force.
A directive is not directly applicable in Member States, it must first be transposed into national law before it is applicable in each Member State.
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UK Regulations
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No. Safety features are relevant only to certain medicinal products for human use (veterinary medicinal products are not within scope). Read the title of the FMD.
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21
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Regulations, part of the EU’s secondary law, are legal acts defined by Article 288 of the Treaty on the Functioning of the European Union (TFEU). They have general application, are binding in their entirety and are directly applicable in EU Member States.
Directives also form part of the EU’s secondary law. Once adopted at EU level, they are then transposed by EU Member States so they become law in the Member States. This can lead to small discrepancies in when different countries have enacted the directive in local law.