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Cosmetics

The Regulation 1123/2009 on cosmetic products makes clear the legislation for the whole European territory regarding:
  • the European electronic notification
  • compliance with good manufacturing practice
  • the drafting of the Product Information File/em>
  • the report on Security
  • information on the safety assessor, restricted ingredients, the use of CMR (carcinogenic, mutagenic or toxic to reproduction) ingredients, nanomaterials, product declarations (claim), on the Specific Obligations for Marketers and Distributors, on the obligation to notify serious undesirable effects.
Cosmetici Pharmintek

Pharmintek is a support service for the following points:

Management of regulatory affairs:

we offer regulatory support to comply with the requirements of labelling, notification, normal and/or simplified, production according to the standards defined at European level, Product Information File design, including safety assessment, supervisory post marketing.

Notification

We support you in collecting the necessary information and documentation and in the notification process.

Legislative conformity of the Composition

The Regulation defines through special lists, prohibited and restricted substances, and provides specific information on dyes, preservatives, UV filters. There are also specific provisions regarding nanomaterials and CMR substances.

But also support for the regulatory evaluation of ingredients, carrying out, if necessary, specific bibliographical research for substances not listed, of unrecognized use.

Labelling and Advertising

Pharmintek is able to work with the customer to define the labeling having regard to the mandatory information and declarations on the product characteristics which must comply with the indications of the Regulation and the common criteria defined by the European Commission, in order to protect consumers from misleading claims about the effectiveness and other characteristics of cosmetic products. Similarly, the advertising of cosmetic products must be adequate and truthful, in accordance with the same common criteria and expressed in terms appropriate to cosmetic products

Traceability

We support companies that market or distribute cosmetics to develop a system that ensures supply chain identification.

Preparation of technical documentation

We prepare the information documentation on the product that must be made available to the regulatory authorities.

Services of Quality Assurance

We support the customer in the revision, development and implementation of the Standards of Good Manufacturing Practice in accordance with EN ISO 22716:2007 Cosmetics - Good Manufacturing Practices (GMP) with Italian transposition UNI EN ISO 22716:2008 - Cosmetics - Good manufacturing practice (GMP) - Good manufacturing practice guidelines..

Cosmetici

Cosmetovigilance

The obligation to record and report to the Health Authorities serious undesirable effects falls on the person responsible for the marketing of cosmetics and distributors, who, if necessary, must put in place appropriate corrective measures. Pharmintek may work with Customers to develop appropriate procedures to comply with this obligation.

Clinical trial

The legislation does not require clinical trials for cosmetics.

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