The import-export of medicinal products is free within European countries only for those products of EU’s origin, while products imported from extra-EU countries and several categories of special products are subjected to Custom controls upon arrival at the destination port or airport. Pharma World interviewed Barbra Bucci, manager at the USMAF Milan Malpensa aeroportual district (which includes all airports located the North-West of Italy), to better examine the regulations and procedures involved in the import of medicinal products in Italy and in the release of the health authorisation to import (Nulla Osta Sanitario, NOS).
USMAFs (Uffici di sanità marittima, aerea e di frontiera) are peripheral organisations of the Italian Ministry of Health located at the main entry ports and airports. USMAF’s offices are responsible for the health vigilance, controls and inspections on all goods imported from extra-EU countries and intended for human use. Goods of animal origin are under the responsibility of the Veterinary services of the Ministry of Health.
«The location of the USMAF’s offices directly at the Italian borders is something unique within Europe, as the other countries usually control goods in locations other than airports and distributed on the national territory», says Barbra Bucci.
The organisation of USMAF
There are 12 USMAF’s offices on the Italian territory. The Milan Malpensa office is responsible for the North West region, including Lombardy, Piedmont and the Aosta’s Valley. Single units are located at the two airports of Milan city, Malpensa and Linate, and in Bergamo (Orio al Serio and Brescia airports) and Turin (Turin Caselle, Cuneo, Aosta airports and the Rivalta Scrivia logistic centre).
Types of products subject to control
Medicinal products arriving in Italy are subject to different Custom procedures and controls according to the type of product and to its origin. Medicines already approved in Italy and for whose the Italian Medicine Agency (AIFA) issued a marketing authorisation (AIC number) can enter freely the national territory. «The import of these products just requires the Custom’s declaration of the AIC number; controls might be then carried on the territory by competent Authorities, i.e. AIFA», tells Bucci.
USMAF’s offices are responsible for controls and for the release of the health authorisations to import for three different categories of medicinal products, as defined by relevant legislative acts.
The authorisation is needed for medicines which have been already approved and are on the market in another European country, but not yet in Italy (D. Lgs. 11 Feb 1997): these products can be imported only upon a specific written request coming from the medical doctor directly in charged of the planning of therapies for a single patient. The provision applies both for medicines produced in Europe and to those of extra-EU origin. «Doctors can prescribe medicines they consider irreplaceable. In this case, the medicinal product must be used only for the indications specified in the marketing authorisation. Off label use is prohibited», explains Barbara Bucci.
Compassionate use of investigational products not yet authorised neither in Italy nor in the European Union is possible for rare, severe or life threatening diseases under the provisions of D. Lgs. 8 May 2003. «The law ask for the demonstration that results from phase 3 studies is available. If the medical doctor in charged of the patient considers essential the use of the product, a positive opinion shall be gained from the ethical committee of the hospital where the therapy will be administered. This opinion is mandatory to import the medicine from abroad», further explains the responsible of Milan Malpensa USMAF. The producer of the investigational product shall supply it free of charge, and it shall open a “compassionate use programme” with AIFA for the supply of the product upon requests coming from interested hospitals. The producer must indicate specific indications for which the import is requested and these must fit with the already performed clinical studies. «The ethical committees of the hospitals interested in compassionate use have to file with AIFA a complete dossier for each single patient to be included in the programme. In order to authorise the import, USMAF’s offices make an evaluation of the positive opinion of the ethical committee. If the documentation is correct, import of the investigational product is authorised», tells Bucci.
The need for the positive opinion from the hospital’s ethical committee applies also to products imported for clinical studies from extra-EU countries. The subsequent procedure is simpler, as clinical studies are already registered in the AIFA’s “Osservatorio delle sperimentazioni cliniche” register, so that there is only need to check the registration number and the ethical committee’s opinion. «Import for experimental use in clinical studies is much greater than those for compassionate use or under the provisions of D.Lgs 11 Feb 1997, that both must remain exceptional measures. This is part of our controls», tells Barbra Bucci. As for the import of medicinal products not yet registered in Italy, for example, the law allows the import just of the quantity needed for a three months treatment. It is also possible for hospitals to ask for the import of a three months ward stockpile on the basis of a motivated estimation of the expected number of patients that might access the treatment. In order to better trace the use of imported medicines, the documentation relative to a single patient must indicate its initials and date of birth. «Some hospitals attach tracking codes and send us separately the corresponding lists of initials and dates of birth, that we use in order to check filing errors. The health import authorisation specifies the person to which the medicinal product is destined, so to facilitate traceability should any problem arise», further comments Bucci. Milan Malpensa’s USMAF office handled in 2014 more than 5600 requests of import for medicines not yet approved in Italy, approx. 3500 requests for compassionate use and 342 requests for clinical experimentation of medicines coming from extra-EU countries. A total of 14.425 requests of import were managed from all Italian USMAF offices in 2014.
The NSIS information system
All procedures needed for the request and final release of the health authorisation to import are managed through the NSIS information electronic system of the Italian Ministry of Health. Users can file all the requested documentation from the public access side of the system. The private access side allows USMAF’s office to check it and to release the final authorisation. «We work in close connection with approved custom brokers, which are different for each of the several USMAF’ offices on the national territory. Data required by the system include name of the importer and of the producer, the foreign courier and the custom broker managing the goods in Italy and foremost their destination of use», tells Bucci.
The procedure used to grant the authorisation depends on the type of filed data. When the user declares closed the filing, a numeric code is generated and sent by e-mail to the USMAF responsible for the documental checking. «The shipping note must be attached in order to trace the itinerary of goods. The authorisation to import can be released only upon arrival of the goods at the national border, not before. We run a documental check and, if necessary, we inspect the goods», tells the responsible of the Milan Malpensa office. The NSIS system records all communications in real time and releases an electronic authorisation when documental checking is positive. Custom receive the notification through the unified electronic counter service “Sportello Unico Doganale” when the file is closed and goods from extra-EU origin can then be authorised to enter Italy. The Custom procedure passing through the Sportello Unico is needed also for communitarian goods, even if they are not subject to Custom control and authorisation. «A paper copy of the health authorisation to import should always be attached to goods up their arrival to the final destination. In some instances, for communitarian delivery courier shipping is faster than the time needed to file and check the documentation. In such a case, hospital pharmacies must wait for the release of the authorisation prior to allow for the use of the medicinal product. The release of the NOS is very rapid, it occurs almost in real time», tells Barbra Bucci.
No need for the authorisation
The health authorisation to import medicinal products is not needed for medicines regularly approved in Italy by the Italian Medicine Agency but that are not available on the market because of inappropriate or time inconsistent modalities of supply by the producer. In this case, import of the product is managed directly by AIFA. The Ministry of Health directly handles the import of psyco-active substances and drugs. Import authorisation is not needed also for medicinal products not intended for diagnostic or therapeutic use, as for example samples for laboratory use, and for pharmaceutical raw materials. This type of products shall be notified directly to AIFA through the NSIS system, and the Agency is responsible for controls.
Custom’s unified counter services (Sportello Unico Doganale)
Import-export procedures are very complexes in Italy, as they may require the notification of the Custom declaration together with the filing of up to 68 other applications involving 18 different authorities. In order to facilitate custom operations, since 2004 the Italian Custom is the unique point of collection and control of all the information needed for custom clearance of imported goods. The electronic unified counter service (“Sportello unico doganale”) is active since 2011 and it is regulated by the D.P.C.M n. 242 dated 4 Nov 2010 (G.U. n. 10 dated 14/1/2011).
Source: Agenzia delle Dogane