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PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.

Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.

Iodine tablets : recommendations for citizens and pharmacists

Over the past few weeks, more than three hundred thousand citizens have obtained iodine tablets from their pharmacies as a result of the conflict in Ukraine. The FAMHP has listed a few recommendations.

The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines

The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market

The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances.

Be careful of your pets when you use hormonal medicinal products on the skin.

In many European countries, side effects have been reported in pets whose owners use transdermal oestrogen-containing medicinal products. The pets came into contact with or licked the area where the medicinal product was applied, usually the upper arm.

Modification of the veterinary prescriptions and the administration and supply document

On 28 January 2022, the European Regulation on medicinal products for veterinary use has entered into force. Among other things, this implies that veterinarians have the obligation to use a new model format for veterinary prescriptions. These changes will take place in several phases.

New European rules on medicinal products for veterinary use as of 28 January 2022

As of 28 January 2022, Regulation 2019/6 became effective. From that moment onwards, European Member States must comply with all rules from this regulation.

Clinical trials: new European regulation enters into force

On 31 January 2022, the Clinical Trials Regulation (CTR) 536/2014 on medicinal products for human use will enter into force. However, the old and the new legislation on clinical trials will coexist during a transition period of three years (until 31 January 2025).

PRAC January 2022 – Review of terlipressin medicines started, update of COVID-19 vaccins and new safety information for Mavenclad

During its January 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of terlipressin medicines. The PRAC also has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen. The PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Mavenclad.

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