REGSHARE s.r.o. offers a comprehensive regulatory service to manufacturers and distributors of biocidal products and active substances.

Biocidal Product Authorisation

Biocidal products in which the manufacturer sees potential will require authorization under the EU Biocidal Regulation 528/2012, to be legally marketed. We will ensure that you obtain the necessary consent as soon as possible. Along with this we will also deal with mutual recognition in other Member States of the European Union.

Checking the Completeness of the Registration Documentation

Do you need to know if your current documents are complete? We offer to check your documents and suggest what you need to add if they are incomplete. In doing so, we look at the economic side of things to minimize costs.

IUCLID Dossier Preparation

We will create an IUCLID dossier for your biocidal product or product family. We will familiarize you with the legislative requirements and provide appropriate testing in accredited laboratories to make the document safe to hand over to the competent authority.

Human Health and Environmental Risk Assessment

For the applicant’s product to be authorised, it is essential that the product is safe for humans, the environment and animals. If the product does not pass the risk assessment, it cannot be placed on the market or only to a limited extent. Assessment is a demanding and highly professional process that can only be performed by experienced professionals.

Registration According to National Regulations

It is not always necessary to undergo a demanding authorization process lasting several years. Depending on the type of product, in some cases it is also possible to place the product on the market under a so-called transitional regime, i.e. when the applicant has to follow only national requirements. This may be a way to keep the product on the market for a transitional period before you have full authorisation for another product or solution for a product that is not your priority but you still want to keep in your portfolio. We have experience with these countries: the Czech Republic, Slovakia, Poland, Lithuania, Latvia, Estonia, Hungary, Slovenia, Croatia, Germany, and Austria.

Representation at the Competent Authorities

We offer help to clients who need to address regulatory issues related to the registration, authorisation or marketing of biocidal products. We will take care of all the necessary formalities, help you resolve complicated issues, or provide you with the necessary information you need to continue to market your products without diffi culty.

Product Portfolio Management

Do you have biocidal products that require regular regulatory oversight? Then we have a solution for you. We will provide you with comprehensive oversight of your products, so you no longer need to worry about whether you have to provide the competent authority with new data, or whether you have missed the deadline for fulfilling certain obligations. We will keep you posted regularly via email on related news.

Product Development Support

If you are thinking about developing new biocidal products, it is essential that they meet all legislative requirements. We will advise you on how to assemble the product properly, what to avoid, or from whom to get the right raw materials.

Strategic Regulatory Consultancy

Knowing the right information is absolutely necessary for every operator in the biocide market. Without key information you will face difficulties, risk administrative sanctions or even be forced to stop your business. Get advice and avoid possible inconvenience.

Labelling and Provision of Mandatory Information on Treated Articles

In some cases, treated articles must be labelled in order to ensure the legal entitlements of downstream users to information on an article’s safety. Observe the regulatory requirements and avoid potential problems that may have serious consequences.

Legal Support

In some cases, uncertain and complex issues need to be addressed together with a lawyer. We have a legal expert with many years of experience.

Assistance in Following the Requirements under Article 95

Since September 2015, biocidal product manufacturers can no longer buy active substances from just any supplier or manufacturer. Their choice has been reduced, so that only those manufacturers and suppliers who meet all the regulatory conditions can remain on the market. Purchasing raw materials from the right suppliers avoids any inconvenience on the part of the regulatory authorities.

Efficacy Assessment

Product efficacy is one of the three most important parameters that biocidal products must meet. Early testing of effectiveness can prevent potential negative consequences that can lead to the rejection of your application to authorise your biocidal product.

Testing the Physicochemical Properties of Preparations, Developing Analytical Methods

For clients, we offer affordable testing in accredited laboratories and the affordable development of analytical methods for the authorisation of a biocidal product. Both must be part of each application for authorisation, so it is essential that it is properly prepared and meets all the requirements.