REGULATORY AFFAIRS BIOCIDES

Our goal is for you to spend your time generating revenue through import and distribution while MDI handles regulatory affairs.

MDI Advisers studies the needs of your company and puts at your service a department that will manage all regulatory matters in Spain and Portugal.

For a Biocide (clinical or healthy skin) to be marketed in Spain and Portugal, it is necessary that:

The company has adequate storage or manufacturing facilities
Have an effective quality assurance system
Have responsible technical staff
The biocide is registered.
(Only a few biocides are registered by the AEMPS: those whose active principles appear in the Annex of Reg. 528/2012, and belong to groups TP1 and TP2)

 

Who are our services aimed at?

We add value to manufacturers, distributors and importers with and without a warehouse that sell or want to sell finished products that have all the necessary certificates for placing on the market.

 

What are your commitments?

Provide us with faithful and truthful information on:

The products you want to market in Spain and/or Portugal
The documentation that supports the quality and safety of said products.
The documentation (technical memory of the facilities).
The documentation of the QMS.

 

What is MDI Advisers committed to?

To carry out all the necessary procedures with the Spanish and Portuguese health administrations so that the product has access to the market in the shortest possible time with full health guarantees.
To carry out the procedures aimed at obtaining the import license.
To develop, implement and monitor the surveillance system:

° Carry out the internal audits that the system indicates and that of your supplier companies.
° Manage claims, withdrawals, no-conformities, etc.
° Prepare an annual plan for the training periods, providing initial and ongoing training to company personnel involved in product quality processes, as well as training new employees.

MDI puts at your disposal specialists in the field who will act as interlocutor with the health authorities, carrying out the administrative procedures necessary to obtain prior licenses and the registration of biocides.

 

What is a biocide import license?

It is a license that authorizes the holder, for a specified period, to import certain biocides from countries outside the EU under the control of Technical Responsible Personnel.

The Spanish Agency for Medicines and Biocides (AEMPS), dependent on the Ministry of Health, is the body that grants these licenses in accordance with the applicable legislation.
The duration of the import license for biocides is usually 5 years, after that time you must renew it.

 

How is an import license for biocides processed and obtained?

The import license is obtained after laborious work in which the requirements mentioned in the following point are submitted to the Spanish Agency for Medicines and Biocides (AEMPS), which depends on the Ministry of Health.
The period for processing and obtaining a license is normally between three and six months, but it can be longer.

Requirements:
Submit a technical report to the AEMPS which demonstrate how the current regulations will be complied with in terms of facilities, processes, certifications, etc.
Have warehouses approved by the AEMPS, either owned or subcontracted. The size of the warehouse will depend on the activity of the company and the type of product.
Have Responsible Technical personnel who, among other duties will be responsible for the release of imported and distributed batches. Without the authorization of the Responsible Technical staff, the company will not be able to market imported products.
An efficient quality assurance system that covers aspects such as claims management, withdrawals, product safety surveillance in the market, traceability, etc.