Early access – medicinal products with special regulations

Petrone Group is organised to support pharmaceutical companies willing to support all pharmaceutical companies will to make available to patients any medicinal products subject to special national regulations.

These drugs are not yet nationally registered or still under national registration phase. Petrone Group plays the role of connecting link between patient affected by relative diseases and the pharmaceutical company doing its utmost to get the drug closer the patient, reducing supplying time.

In many cases, the absence of a therapy, for example due to an unusual or rare pathology in our country, can be solved using an innovate drug. It is possible that this medicine is not yet registered in Italy or it is under registration phase. Shortage of a drug at national level, due to production problems, can be overcome thanks to specific and dedicated import procedures.

It is in this respect that the distribution must be validated by unique features and the drug use must follow any prescribed terms and procedures authorised in the source country, as well as complying with the Italian current regulations.

Import/export – Early access – medicinal products with special regulations

Our offer

Petrone Group, under direct mandate of Marketing Authorization Holders pharmaceutical companies will be made possible supplies of:

  1. Innovative medicines that are legally commercialised in other countries but not in the national one;
  2. Medicines not yet authorised but under clinic trial;
  3. Off-label medicines to be used for therapeutic indications additional to the authorised;
  4. Medicines that are still under national licencing process but already EMA approved.

Dedicated service

Our services cover:

  • logistics
  • distribution
  • pharmaceutical management in cross docking
  • direct delivery to patients, pharmacies or hospitals
  • completion of all import formalities and security clearances management
  • in-transit management
  • temperature controlled and refrigerated drug management
  • tracking inventory management
  • full traceability system

The entire management is carried out by specialised pharmacists, focused to such medicine categories.