Product Information File (PIF)

Podatkovni dosje kozmetičnega izdelka

Vsak kozmetični izdelek, ki je namenjen trženju na evropskem trgu, mora imeti pripravljen celovit podatkovni dosje v skladu z Uredbo (ES) št. 1223/2009 o kozmetičnih izdelkih in njenimi dopolnili.

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What Does the Product Information File (PIF) Include?

  1. Signing of a confidentiality agreement immediately after the agreement is made
  2. List of required documentation sent to your email
  3. Start of documentation preparation upon payment of a 50% advance
  4. Detailed product formulation: complete list of ingredients with proper INCI names
  5. Raw material and packaging specifications: compliance check with regulatory requirements
  6. Physicochemical analysis: determination of product stability, pH value, viscosity, and other key parameters
  7. Microbiological analysis: verification of product safety under normal use.
  1. Stability and stress testing: ensuring long-term safety and product effectiveness
  2. Cosmetic product safety assessment: risk assessment conducted by a properly qualified safety assessor
  3. Manufacturing process data: quality control and compliance with Good Manufacturing Practice (GMP) standards
  4. Usage instructions and labeling: preparation of proper usage guidelines and packaging compliance review
  5. Product notification in the CPNP portal
  6. Delivery of the complete documentation in printed or electronic form, after full payment is received.

Zakaj mi zaupajo mnogi

  1. Imam več kot 17 let izkušenj in strokovnega znanja v farmacevtski industriji in več kot 10 let pri razvoju kozmetičnih izdelkov.
  2. Sodelujem s strokovnjaki iz področja farmacije, dermatologije, kozmetologije in fizioterapije za optimalne rešitve.
  3. Spremljam regulative in novosti, kar zagotavlja varnost in skladnost izdelka s kozmetično zakonodajo.
  4. Vsak korak izvedem natančno, preučim surovine, ocenim komedogenost, stabilnost in kompatibilnost ter preverim omejitve uporabe sestavin.
  5. Izdelek obremenim in stabilnostno testiram, da se zmanjša potreba po kasnejših korekcijah sestave, kar vam prihrani čas in stroške.
  6. Podprem vas pri prodaji in vam pomagam vam pri inšpekcijskih pregledih, da se zmanjša tveganje za morebitne kazni.
  • dr. Rebeka Prislan