Change in withdrawal periods and restriction to route of administration in food-producing animals treated with injectable veterinary medicines containing Vitamin A

Notice type: Advisory

Date: 12/01/2022

Consequent to an evaluation by the European Medicine Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) earlier this year, the withdrawal periods for milk, meat and offal of food-producing animals treated with injectable veterinary medicinal products containing Vitamin A has been significantly increased.

In addition, the subcutaneous route of administration is no longer approved in food-producing animals.

Also, a number of warnings have been established including not to administer to animals with adequate vitamin A supply, not to exceed the recommended dosage, not to give repeated injections, not to use for prevention of vitamin deficiencies and not to be administered by pregnant women.

Product name or type:
Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs

Authorisation Number:

Active Substance:

Vitamin A (retinol palmitate)

Product Classification:

The concerned products are injectable Vitamin A preparations for administration to food-producing species.

Authorisation Holder:

Bela-Pharm GmbH & Co. KG

Target Audience:

Veterinary practitioners, pharmacists, licensed merchants, farmers.

Problem Or Issue:

The German veterinary regulatory authority identified that the withdrawal periods for vitamin A and user safety warnings differed between EU Member States and initiated a referral procedure to the European Medicines Agency to request that the Committee for Veterinary Medicinal Products (CVMP) conducts a review of the safety of injectable veterinary medicinal products containing Vitamin A for use in food-producing species.

The CVMP concluded that the withdrawal periods for milk, meat and offal for food producing animals should be amended (increased) and certain warnings should be included in the product information [summary of product characteristics (SPC), labelling and package leaflet] in order to provide assurance for consumer and user safety.

In light of the CVMP’s opinion, the European Commission subsequently issued a final decision ((2021)6223 of 18 Aug 2021) to implement the outcome of the referral procedure in the Member States.

As a consequence of the above, the HPRA has recently amended the marketing authorisation of Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs (VPA10445/006/001), in order to implement the Commission decision.

The following changes arise:

  • The meat & offal withdrawal periods have been increased as follows:

    Cattle: 259 days, Pigs: 194 days and Horses: 250 days.

  • The milk withdrawal period for cattle has been increased as follows:

    Cattle: 120 hours (5 days).

  • The product may no longer be administered subcutaneously in cattle, pigs or horses (only the intramuscular route may be used).

  • The product should not be used in food-producing animals with adequate Vitamin A supply due to the possibility of accumulation in edible tissues.

Actions To Be Taken:

The HPRA advises veterinary practitioners and users of this veterinary medicinal product to follow the updated conditions of the marketing authorisation, as set out above and on the HPRA website pending the availability of new stock with updated labelling and package leaflet reflecting the changes outlined above.

As with all veterinary medicines, any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.

Further Information:

Further information on the European Medicine Agency’s review including the CVMP’s opinion is available from the EMA website

The European Commission’s decision is available on their website.

The labelling of the affected products is being updated to reflect the amendments required in the Commission decision. 

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