On 11 November, GM International received from the UOC Pharmaceutical Supervision the official notification of the authorization for the deposit activity and for the subsequent distribution of active substances, as required by Article 108 bis of Legislative Decree 219 of 24 April 2006.
The communication states that GM International is compliant with all the obligations envisaged by the legislation, including the preparation of a dedicated warehouse for active substances, the passing of an inspection by the ATS Supervisory Commission, the identification of a Technical Director, who is responsible for the activity and the organization of an updated list of all the treated substances.
The distribution of drugs, medicines and active substances is an activity, which requires specific skills in order to guarantee the integrity of the product and the prevention of fraud and counterfeiting. For this reason, it is subject to specific and very stringent regulations, both nationally and internationally.
In particular, on April 24, 2006 Legislative Decree 219 ruled the implementation of EU Directive 2001/83 concerning a common Community code for medicinal products for human use. Article 108 bis of this decree establishes that distributors of active substances established in Italy must register their activity with the competent territorial authority, which carries out the necessary inspections and after having verified the existence of all the legal requirements, allows the start of the activity.
GM International warehouse in Lainate has a dedicated area where active substances are stored. There, the correct temperature, humidity and light exposure conditions are guaranteed in order to prevent any chemical-physical transformation to the active principle. The warehouse is also designed for the correct traceability of each substance and for total access control to ensure no counterfeiting.
This certification is only the last step of a path of excellence GM International started some years ago, regarding the warehouse management of pharmaceutical products and it is complementary to the Good Distribution Practice certification obtained by the company in 2017.
“GM International has many years of experience with companies in the chemical-pharmaceutical sector. The certifications obtained are the result of an important investment by the company in this sector and also the right recognition of our ability to guarantee high quality services to customers “, said Flavio Malaterra, CEO of GM International.