Adverse events can occur in connection with the use of a veterinary medicinal product (VMP). Besides any unfavourable and unintended reaction in an animal suspected to be related to a VMP they also include:

• a lack of efficacy of a VMP
• an insufficient withdrawal period, e.g. findings of an active substance or marker residue exceeding the established maximum residue levels in foodstuffs of animal origin
• interactions with other VMPs
• events occurring after the intended or unintended use of a VMP in humans
• negative effects on the environment

Adverse events following the use of medicinal products for human use in animals should also be reported.

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AE can be triggered by both veterinary medicinal products and medicinal products for human use.

Medicinal products are only authorised after careful examination by the competent authorities and in accordance with legal regulations. For example, results of extensive studies on the efficacy and safety of medicinal products must be submitted by the applicants. Nevertheless, it is still possible that adverse events are observed after marketing authorisation that were not identified during the marketing authorisation procedure.

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In principle, all undesirable events that are suspected to be related to the administration of a VMP can be reported as AE. These may, for example, be unfavourable and unintended reactions of the treated animal to a VMP or a lack of or reduced efficacy of the VMP.
Observed AE are often already listed in the package leaflet. However, if an animal shows clinical signs not described in the package leaflet, this could be an indication of a previously unknown AE. If suspicious events are observed, a veterinarian should be consulted to evaluate the case.

Both known and unknown AE should be reported.

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In principle, all animals can be affected by an AE. This applies not only to animals that have been intentionally treated with VMPs, but also to animals that have accidentally come into contact with the VMP. For example, animals living in the same household or stable may come into contact with the VMP via treated animals. Wild animals may be exposed to a VMP via contamination of the environment. These aspects are also taken into account when assessing the safety of VMPs.

If there is reasonable evidence that there is a risk to other animals or the environment, measures can be taken to minimise the risk. For example, the package leaflet of some VMPs states that treated animals should not be allowed to enter surface water for a certain period of time after application. The package leaflet may also contain warnings regarding incompatibility with certain species, such as cats, informing users of an increased risk if these VMPs are misused in cats or if cats come into contact with treated animals.

Therefore, reports of AE in animals which have unintentionally come into contact with a VMP or where exposure of the environment is suspected are also valuable sources of information for monitoring the safety of VMPs.

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In most cases, VMPs are administered by veterinarians or animal owners. They may accidentally come into contact with the VMP, for example during administration or through accidental self-injection. In these cases, humans can also react to VMPs. Such reactions may differ from the known reactions in animals both in terms of their symptoms and their severity. If an AE occurs in humans after contact with a VMP, this should be reported to BVL.

In general, humans should avoid direct contact with VMPs as much as possible.
Before using VMPs, the package leaflet should be studied carefully and taken into account with regard to the instructions for use. If necessary, protective equipment such as gloves should be worn.

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The marketing authorisation procedure of VMPs includes testing their efficacy, quality, such as purity of active ingredients, and safety. However, VMPs are tested on a limited number of animals. This means that not all breeds, age groups and husbandry conditions can be taken into account. It is therefore possible that rare AE or problems with use only become apparent after marketing of the product, leading to widespread use under practical conditions.

Continuous monitoring of all VMPS after marketing authorisation is therefore integral in ensuring drug safety.

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Known AE are listed in the package leaflet of the respective VMPs. If, on the basis of new findings, measures are taken about which the public needs to be informed, this is done via BVL press releases, announcements on the BVL website, newsletters, social media and journal publications.

The European Medicines Agency (EMA) provides public access to reported AEs related to VMPs authorised in the European Union.

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Further information, contact details, forms and links for reporting can be found here.

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The reporting of AE actively supports the safety of VMPs! Although VMPs are subject to high standards of efficacy and safety, it is possible that undesirable and unforeseen effects may occur after placing on the market following widespread use. Rare reactions, unknown interactions with other medicinal products or increased sensitivities of certain animal groups (e.g. age groups or animal breeds) sometimes only become apparent under practical conditions and with very high numbers of treated animals. The reporting and evaluation of AE is therefore essential for the safety of VMPs.

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If you suspect an AE affecting you or your pet/livestock animal, you should consult your attending veterinarian or general practitioner. Even if the AE is already listed as a known possible adverse event in the package leaflet of the VMP, it should be reported by you or your attending veterinarian.

Clinical signs occurring after accidental exposure to a VMP or after treatment with a VMP that is not authorized for the species concerned, as well as a lack of expected efficacy or negative effects on the environment should also be reported.

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AE can be reported by animal owners as well as other affected persons and veterinarians. Reports can be submitted to the BVL or the pharmaceutical company marketing the respective VMP. Reports can be submitted to the BVL online, via telephone, mail or e-mail. All reports are processed in compliance with data protection regulations.

If the suspected AE is reported to a pharmaceutical company, it is legally obligated to forward the information to the European Medicines Agency (EMA).

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For reporting AE you can use our pdf reporting form.

For reports via mail, telephone or e-mail, contact details can be found here.

Alternatively, you can submit your report via our online reporting form. 

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If your pet/livestock animal is affected by an AE after treatment with a VMP, you can report this to the BVL. The Paul-Ehrlich-Institut (PEI) is responsible for AE occurring after treatment with immunological VMPs (for example vaccines).

In both cases you can either use our pdf reporting form or our online reporting form. 

For reports via mail, telephone or e-mail, contact details can be found here.

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If your pet/livestock animal is affected by an AE after treatment with a medicinal product for human use, please report this to the BVL.

You can either use our pdf reporting form or our online reporting form. 

For reports via mail, telephone or e-mail, contact details can be found here.

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AE that occur in a human after contact with a VMP should be reported to the BVL. The Paul-Ehrlich-Institut (PEI) is responsible for AE occurring after contact with immunological VMPs (for example vaccines).

In both cases you can either use our pdf reporting form or our online reporting form. 

For reports via mail, telephone or e-mail, contact details can be found here.

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AE occurring in humans after treatment with a medicinal product for human use should be reported to the Federal Institute for Drugs and Medical Devices (BfArM).

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Yes, absolutely! Negative effects on the environment after the use of a VMP represent AE and should be reported to the BVL. This can help to ensure that new instructions for safe use are added to the package leaflet of the respective VMP.

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For an AE report to be valid, at least the following details are needed:

• Identifiable reporter
• Species and number of animals affected
• Product/Brand name of the VMP (at least active substance is needed)
• Details on the AE, for example clinical signs observed in animals or humans or lack of expected efficacy

Other important information include breed, sex, age and body weight of the affected animal, treatment details such as dosage, date of treatment, exact timeline of event, concomitant medication as well as pre-existing diseases. The more detailed the information in the report, the better a causal relationship between contact/treatment with the VMP and observed AE can be assessed. All of these details are provided on a voluntary basis.

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Should the electronic reporting system fail, AE can be submitted to BVL via mail, fax or e-mail (postal address: BVL, Gerichtstr. 49, 13347 Berlin; Fax: +49 (0) 30 18 444 – 30409; e-mail: uaw@bvl.bund.de).
Reporting forms can be found on the BVL website (bvl.bund.de/uaw-formular) or here.

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AE reports submitted to the BVL are processed and evaluated by veterinarians. They are entered into the German pharmacovigilance database and subsequently forwarded to the AE database of the European Medicines Agency (EMA) in anonymised form. AE reports are then available to competent authorities of all European member states for further analysis. Since 2019, there has been public access to this European database, which allows interested parties to carry out limited searches.

According to the new Regulation (EU) 2019/6 on VMPs, an assessment of the causal relation between administration of the VMP and the reported AE is no longer mandatory. Nevertheless, veterinarians at BVL continue to conduct a causality assessment, as it improves data quality for subsequent statistical analysis.

Risk assessment is regularly performed by applying statistical methods. If an increase in previously unknown AE is observed, suitable measures are taken, such as listing additional AE or instructions for safe use in the package leaflet. In very rare cases, the marketing authorisation of a VMP can be suspended or revoked.

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Before application of the new Regulation (EU) 2019/6 on veterinary medicinal products in 2022, the ABON-system was used to assess a possible causal relation between treatment with a VMP and an AE.

According to this system, a possible causal relation is classified as:

A – probable
B – possible
O – unclassifiable/inconclusive
N – unlikely.

Criteria for the assessment of causality are, for example, the temporal relationship between the administration of the VMP and the AE observed, the pharmacological-toxicological properties of the active substance or other constituents of the VMP, the presence of previously reported cases in the database or other possible causes for the observed AE

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Generally, AE reports will be forwarded in anonymised form to the European Medicines Agency (EMA). Personal data will only be used by BVL for further enquiries with regard to the reported case, but will not be forwarded to third parties.

Information on data protection according to Art. 13 and 14 of EU General Data Protection Regulation (GDPR) for the processing of AE reports can be found on the BVL website (bvl.bund.de/privacy-policy) or here.

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No. Because the logo does not have any validity on its own!

But with three simple steps you can reduce the risk of ordering from websites of dubious suppliers:

1. click

Click on the logo: If the online retailer is included in the register, a BVL web page opens with the register entry of the retailer who has a permission for online trade with VMPs.

2. check

Check whether the website address (URL) in the browser line of the retailer´s entry in the register is marked with a lock symbol and begins with www.bvl.bund.de/ after https://. Pay special attention to the slash (/) after ".de".

The lock symbol in the browser line shows you that the website is trustworthy (in different colours and designs depending on the browser used). It confirms that the page has a valid security certificate and that the connection is secure. Convince yourself that you are actually on a BVL website by clicking on the lock symbol and opening the certificate.

3. buy

Re-open the website of the retailer for VMPs via one of the links provided in the register for online retailers. Do not use the "back" function of your browser and do not go back into a window that may still be open.

If no entry in the register for online retailers is opened when clicking on the logo, this may be due to one of the following reasons:

• The logo was installed incorrectly.
• There is a technical error.
• It is a dubious provider who misuses the logo.

Learn more about sub-standard and falsified medicines

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Yes, the EU safety logo may only be used on registered websites. Furthermore, the logo is protected by copyright. The German safety logo may not be used without the consent of the BVL.

The use of the logo by online retailers for VMPs is basically limited to the link from the website of the retailer to the respective register entry of the BVL.

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No. The competent authorities pursuant to German federal states (Laender) law, which also issue the online retailer licence, are responsible for monitoring retailers for VMPs.

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The page does not have to be fake. To check whether the logo nevertheless appears legitimately on the website of the online retailer, see if you can find him in the overview of all registered online retailers.

Other reasons why the click on the logo does not lead to a register entry:

The logo was installed incorrectly.

There is a technical error. Try again later again, if the access the register entry works.

It is a dubious provider who misuses the logo.

Learn more-about the EU safety logo

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Registered retailers must present the logo on their websites. To find out whether the retailer in question is registered, please also refer to the overview of all registered online retailers.

If the logo is missing on the website and the online retailer is not listed in the register either, there may be several reasons for this:

• He has a permission for online sales of VMPs, but is not yet registered.
• He does not have a permission for online trade with VMPs.
• It is a dubious provider.

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If you are not yet registered in the BVL register for online retailers:

To be included in the register for online retailers, please contact the supervisory authority responsible for you in the German federal states (Laender). They will forward the necessary documents to the BVL. As soon as your entry appears in the register, the BVL will send you information on how to place the EU safety logo on your website(s).

How to use register for online retailers

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No. The BVL Register only contains online retailers of veterinary medicinal products.

The register of online medicinal products for human use is kept by the BfArM and can be accessed by using the following link:

German Register of Online Medicine Retailers

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You cannot find the retailer in the list? This may be due to the following reasons:

The online retailer has a permission for online trade with veterinary medicinal products but is not yet registered.

The online retailer has no permission for online trade with veterinary medicinal products.

The online retailer is not located in Germany; you may be able to find him on the site of another EU member state:

List of registers of online medicine retailers

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No. Please contact the competent German federal state (Laender) authority for this particular retailer, which you can find in the register of online retailers.

They also have the right to take legal action. The BVL is merely the authority keeping the register.

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Yes, but please note that online retailers from other EU Member States may only send veterinary medicinal products to Germany that are authorised in Germany and classified as non-prescription veterinary medicines. There may be differences in the classification of veterinary medicinal products between Member States.

Each EU country keeps its own register for online retailers that are located in the respective country. You can recognise registered retailers by the EU safety logo with the flag of the respective country on their websites. For more information on online retailers in other European Member States, please visit the European Medicines Agency (EMA) website by using the following link:

https://www.ema.europa.eu/en/veterinary-regulatory/overview/buying-veterinary-medicines-online

The BVL is not a supervisory authority for online trade with veterinary medicinal products and cannot warrant the legitimacy of online offers of veterinary medicinal products.

If you would like to order veterinary medicinal products from online companies based in other Member States, please refer to our FAQs.

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Information about the legal status of supply of veterinary medicinal products authorised in Germany can be found in the Drug Information System at www.pharmnet-bund.de

Please note that query form is only available in German.

Select Search Access in the Drug Information System.

Select the following parameters in the query form:

Human- oder Tierarzneimittel

„Tierarzneimittel“

Verkaufsabgrenzung

„freiverkäuflich“

or

„apothekenpflichtig“

Finally press button

Suche starten

Here you will find a list of all veterinary medicinal products that are available prescription free, either OTC only in pharmacies (“apothekenpflichtig”) or OTC in less well- regulated outlets (“freiverkäuflich”).

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