Registration and re-registration of medications and dietary food supplements

We offer qualitative and fast registration process, based on the long-term experience and understanding of the legislation and different registration requirements in the Baltic States. This type of services allows you saving time and human resources. That in its turn will allow faster and more dynamically promoting products both in the Latvian and Baltic markets.

It is necessary to understand the registration procedure correctly in order to register successfully

The regulatory acts, which provide the different conditions for the classification and registration of the medicines and dietary food supplements, vary greatly in the different countries. The EU countries have similar requirements, however they also vary. The USA and Russia also have the different requirements for the registration of dietary food supplements. The requirements for the registration of dietary food supplements, dietary food supplements and sports nutrition are also different. For this reason, sometimes a situation arises, when you have to face difficult situations on the way to the product registration in the Latvian Republic.

Who is responsible for the registration procedure in the Republic of Latvia?

The Food and Veterinary Office is responsible for the registration of the dietary food supplements, dietary food and sports nutrition, and the State Agency of Medicines is responsible for the registration of the medicines in the Republic of Latvia. It is very important to execute documents correctly, as upon considering all the submitted documents the Food and Veterinary Office or the State Agency of Medicines makes decision whether to register dietary food supplements or corresponding medicines in accordance with the regulatory acts. According to the results of practice, the most popular in Latvia are the dietary food supplements, which are registered in the Food and Veterinary Office, then the product is safe and complies with the requirements.

How do we help our customers?

Often, before becoming the customers of our company, other companies face the problems of wrong development of the advertising of the dietary food supplements and medicines. It is widely met that the dietary food supplement is advertised, but the advertising has been incorrectly developed. The corresponding links, which are required by the EU directives, are not indicated. The great problem is the complex process of execution of the documents. 13 years of experience in the pharmaceutical industry provide our customers an opportunity to get fast and high-quality process of registration and correct execution of documents.

What is a dietary food supplement and which is the process of the registration of dietary food supplements?

Dietary food supplement – food substances for supplementation of the nutrition. This concentrated nutrient substances (vitamins and minerals) or other substances that have nutritional value or physiological effect, alone or in combination, and are distributed and sold in doses – in capsules, pastilles, tablets, pills, powder packets, ampules and other containers, which are designed for use in small to moderate quantities.

It is allowed in Latvia to import and distribute only dietary food supplements that are registered in the register of dietary food supplements, except for cases, when the samples for registration are imported the request of the Food and Veterinary Office… Find out more information by contacting the experts of the company “Infarma”.

What do you need to register dietary food supplements from a third world country?

In order to register dietary food supplements produced in a third world country and not yet introduced to the market of the European Economic Area, the appropriately executed supporting documentation should be provided to the Food and Veterinary Office… Find out more information by contacting the experts of the company “Infarma”.

What is a diet food (sports nutrition) and its registration?

Dietary food nutrition, which by its particular composition or as a result of the production process is clearly distinguished from the usual food substances, is suitable for specific nutrition purposes, and which suitability is indicated in sale. Dietary food is marked in accordance with the requirements, which are defined in the legislation on food marking.

Manufacturer of the diet food, the importer, if the diet food is produced in a third world country, the distributor or the presenter informs the Food and Veterinary Office of such diet food before its first introduction in the Latvian market: artificial infant formula; diet food for people with health problems; food products that do not contain gluten; food products that are provided in cases of intense muscle strain, especially for athletes – sports nutrition; food products for people who have carbohydrate metabolism disorders (diabetes); other diet food, except for diet food products, to which a legislation on artificial infant formula is applied, food for infants and young children, food products with low energy value, which are intended for weight reduction.

Sports nutrition – food products, which are provided in cases of severe muscle strain, especially for athletes.

What are medical devices and their registration?

Medical device any instrument, apparatus, object or material (as well as the software, which is necessary for the use of the device in accordance with the instruction), which should be used separately or in combination by using for diagnosis and treatment of the diseases, prevention, monitoring, pain relief, for compensation in case of wounds or injuries, for the study of the human anatomy and physiological processes, for the replacement or transformation, for the examination of the medical concepts, and the main activity of which in relation to the human body is not achieved by pharmacological, immunological or metabolic means, but they can be used for the operation of the device.

The competent authority for registration of medical devices and assessment of the conformity is the State Agency of Medicines.

Examples of advertising development in accordance with the normative references of the Republic of Latvia

There are different peculiarities in the marking, advertising or description of food additives and dietary or sports nutrition. There are specific references to health and obligatory reference to harmlessness and marking requirements. For example, the marking of dietary food, the used marking techniques, design and advertising should not be misleading (for example, it is restricted to attribute non-existent product properties or indirectly indicate that they can prevent, treat or cure a disease). It is allowed distributing only useful information or recommendations, which are intended only for specialists of medicine, nutrition or pharmacy.

What should be done if the marking text is changing?

If the registered or existing marking of the food additive, the manufacturer, the conditions of the production or use are changing, the presenter is obliged to inform the Food and Veterinary Office in writing within 30 days.

The opportunity to reduce costs!

By properly completing the registration process for the introduction in the market of the products – food supplements, dietary nutrition, medicines of the European Economic Area, our consultants will help you choose the most suitable and cost-effective opportunity for execution and registration of supporting documents and submission procedure in various European countries.

Free consultations on the registration options

Use the opportunity to get free advice in person. We will provide information about the specifics of the pharmaceutical industry, as well as about our services and achieved results. We adapt the service to your requirements as much as possible. Learn more about the service!


Please enter phone and email*



Please enter name or company name*



* No spam. Contact information is used only for a free consultation.

Find out more information by contacting the experts of the company “Infarma”.

For more information please call +371 28818603 or email info@infarma.lv !

… Please click and receive full list of our services.

Atbildēt

Jums ir jāielogojas lai atstātu komentārus.