Obtaining the marketing authorisation for narcotics is a delicate procedure, regulated by specific norms whose compliance is carefully monitored by the Italian Ministry of Health.
The authorisation to the wholesale of narcotics and psychotropic substances and all their preparations is issued by the central narcotics office of the Ministry of Health. It authorises those who obtain it to carry out business operations in Italy, in the European Union and in the rest of the world.
Not every stakeholder of the pharmaceutical chain can, however, apply for this authorisation. For narcotics, the regulations in force provide for a very limited list of subjects that can apply for it and get it: warehouses and wholesalers of human and veterinary medicinal products having a specific regional authorisation and the MA holders and sale concessionaire performing wholesale activities using authorised warehouses or wholesalers.
Narcotic manufacturing should also be preliminarily authorised by the Ministry of Health. The authorisation application for the manufacturing or use of narcotic drugs implies the submission of some documents, varying according to the type of applied authorisation, but usually including a copy of the authorisation to manufacture or distribute human and veterinary medicinal products.
Certificates or self-certifications regarding the registration at the Chamber of Commerce, any court records, any pending charges, the residence or family status of the holder, the legal representative and the technical director. For the latter, a self-certification on the qualifications as well as the acceptance of the appointment should also be submitted. Finally, along with the payment receipt of the relevant ministry fee, the blueprint of rooms dedicated to the storage and/or manufacturing of narcotics and all the characteristics of the building where they are located, including any safety measures, insurance, etc.
The forms made available by the Ministry on their official website include a detailed list of the documentation to be enclosed depending on the type of application (first authorisation or renewal of the authorisation for narcotics), the type of activity and the subject requesting it.
It is also possible to submit an application to change the existing authorisations such as the replacement of the Responsible Person or the Legal Representative, the transfer of the warehouse or the move of the room/armoured cabinet/safe inside the same warehouse, etc.
The application can be submitted to the central narcotics office via certified e-mail (PEC), by selecting one single option. The regulations provide for an outcome within 90 days from the date of reception of the application by the Ministry; however, this timeline can be suspended in case of requests of integrative documentation by the office. The outcome is sent via PEC: once it has been obtained, the authorisation will be valid for two years and can be renewed submitting the relevant application at least 3 months before its expiry.
The reference regulation is the Consolidated Law regarding narcotics and psychotropic substances, and prevention, care and rehabilitation of drug addictions contained in the Presidential Decree 9 October 1990, no. 309.
This includes, among other things, the tables listing all substances and narcotic preparations indicated in the international conventions and agreements, to be promptly updated based on new scientific knowledge. The tables list all isomers, esters, ethers and salts, and report the international non-proprietary name, the common usual name in Italy and the proprietary name of the marketed pharmaceutical product.