Cosmetic legislation is a rather tricky area of the law. Our team of professionals takes all the necessary steps to ensure correct distribution in both European and non-European markets. Vivipharma internally draws up Product Information Files (PIFs), prepares technical and safety data sheets, submits notifications to the European Portal, requests for over-the-counter sales certificates and issues good manufacturing practice certificates and so forth.
More specifically, we are responsible for:
COSMETICS FOR FACE, BODY AND HAIR
— Ensuring formulas comply with the requirements of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council.
— Constantly monitoring legislative updates in order to always provide clients with the corresponding update and compliance with applicable law.
— Providing support when selecting the compliance, safety and efficacy testing to be carried out on a product.
— Choosing The correct wording to be placed on the label and in the claims, as well as the required and approved symbols, when preparing the artwork.
— Preparing PIFs (Product Information Files) and the corresponding product safety assessment.
— Providing support and submitting notifications to the European CPNP (Cosmetic Products Notification Portal).
— Providing support and submitting notifications to the National Health Institute (ISS) of San Marino.
— Providing support when preparing the required documents for export to non-EU countries.
COSMETIC RAW MATERIALS
— Documentation and safety data sheets pursuant to Regulation (EC) 1907/2006 as amended.
— Data sheets with specifications and monographs.
— PIFs and supporting statements.
— Ensuring compliance with the main international inventories (IECIC, DSL/NDSL ICL AICS, etc.).
— Filling out COSMOS, ECOCERT, NATRUE questionnaires.
— Being continuously available should clients need any additional documentation (filling out questionnaires, setting up additional efficacy tests…)
DIETARY SUPPLEMENTS
— Ensuring formula compliance and bringing formulas into line with the requirements of the Ministry of Health, Directorate-General for Hygiene, Food Safety and Nutrition.
— Drawing up technical data sheets.
— Providing support when selecting the safety and efficacy testing to be carried on a product
— Choosing the correct wording to be placed on the label and in the claims, as well as the required and approved symbols, when preparing the artwork.
— Providing support and submitting notifications to the European CPNP (Cosmetic Products Notification Portal).
— Providing support when preparing the required documents for export to non-EU countries
COSMETOVIGILANCE
Cosmetovigilance pursuant to Regulation (EC) No. 1223/2009 on cosmetic products and its application in Italy.
According to art. 23 (paragraph 4, Communication of serious undesirable effects), both health professionals (general practitioners, dermatologists, hospital and territorial pharmacists etc. …) and end users (consumers or professionals who use and apply cosmetics in a professional capacity) can report Serious Undesirable Effects by filling out a national form defined by each European Union Member State.
The FORM FOR REPORTING A SUSPECTED ADVERSE REACTION TO A COSMETIC can be downloaded from our website or requested from the Scientific Director by calling 8000-13099
