Biocide requires proper planning to successfully obtain authorization for biocidal products in EU. Biocides are regulated in the EU with Regulation (EC) No. 528/2012 (BPR) and need to be authorized before they can be placed on the market. Auxilife support in all PT types (Product Types) for all 4 main groups. At the moment there are two possibilities for placing biocide products (BP) and their product types (PT 1 to PT 23) in the market:
Under transitional measures
Under BPR/EU rules

Submissions under transitional measures:
If the active substance is yet not included on the EU positive list of active substances, then you need to follow national procedures. It is not harmonised across different EU countries.
Since, 1st September 2015 all suppliers of the active substance must be included in the Article 95 list of the product type for which the product is intended to be used and placed in the market.
Key Services

• Outline on the status of your active substance
• Strategic support to understand the registrability
• Regulatory compliance with Article 95 obligations
• Interested country specific guidance and local support
• Document submission and post submission support

Submissions under BPR/EU rules:
Auxilife support you for below category of registration:

• National authorization with option to apply for mutual recognition in other MS
• Union authorization
• Simplified authorization
• Authorization for same product

Applications for Union authorisation shall be submitted to the European Chemical Agency. The Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State.
Key Services

• Strategic advice and guidance for your specific active substance
• Data Gap Analysis and evaluation
• Data generation management and study monitoring
• Task Force/Consortia management
• LoA- Letter of Access support
• Dossier preparation, submission and post submission
• Simultaneously handling submissions in multiple countries
• Communications with local authorities
• Follow up on the dossier under evaluation

Project Management
At Auxilife we are aware of the fact that some time deciding about a regulatory strategy is disproportionately cumbersome. Therefore, to lift up the burden Auxilife has designed a procedural model that begins with the understanding of your aspiration and your product. And then gearing to the development of tailored strategies suiting to your product and budget estimates. In the summation we evaluate and analyse relevant factors that will come on the way of registering your product. We advise, do preliminary assessments and design a way forward to meet all regulatory compliance. A point of contact will help you through out submission graph and will support you in technical needs.