Issue of Health Clearance (N.O.S)

Cosmetic product already notified pursuant to law 713/86

It must be the subject of a new notification on the European Commission portal CPNP (Cosmetic Products Notification Portal) in the event that, as of 11 July 2013, the responsible person continues to place further units of the same product on the market. Therefore, those cosmetic products already made available on the market before 11 July 2013 and intended to no longer be placed on the market after that date are not subject to electronic notification on the CPNP portal, as they will run out. Only for those that will be imported and placed on the market from 11 July 2013, as regards the documentation to be presented, point 4 below applies.

Semi-finished cosmetic product, coming from third countries, imported by so-called third-party producers, to be reworked, packaged and marketed in other countries of the European Union under various brands

In such cases, the centralized notification to the CPNP may not have been carried out, precisely because marketing is not immediate, but the product is stored to allow further processing. There may also be a notification, but as it concerns producers who are not ready for marketing, it may not contain all the necessary data. Produce the following documentation:

– substitutive declaration for import purposes for semi-finished cosmetics (Annex 1);

– photocopy of a valid identification document of the signatory of the declaration;

– commercial documentation (invoice) with the list of all imported products in order to verify their correspondence.

“Finished” cosmetic product imported, but not notified on the portal, because the responsible person (ex art. 4, EC reg. 1223/2009) does not intend to place it on the market immediately

In this case the notification will be subsequent to the entry of the goods, before they are placed on the market. Produce the following documentation:

– substitutive declaration for import purposes for finished cosmetics (Annex 2),

– photocopy of a valid identification document of the signatory of the declaration,

– commercial documentation (invoice) with the list of all imported products in order to verify their correspondence.

“Finished” cosmetic product intended for placing on the market

Produce the following documentation:

– photocopy of the CPNP, or reference cosmetic product code in the CPNP portal;

– commercial documentation (invoice) with the list of all imported products in order to verify their correspondence.

Semi-finished product in transit

Nothing changes compared to the procedures currently in place: the issuing of the n.o.s., or any other authorization documents, is the responsibility of the territorial Usmaf of destination indicated on the T1 transport document.

Cosmetic product for personal use

Nothing changes compared to the procedures currently in place. Produce the following documentation:

– personal use declaration form (annex 12b);

– photocopy of a valid identification document of the signatory of the declaration.

Cosmetic product intended for technical testing/sampling/display

Nothing changes compared to the procedures currently in place: for the request for the n.o.s. it is necessary to fill in and send the dedicated form (attachment 3), as well as the payment of the relevant tax.

MEDICAL DEVICES

– self-declaration for medical devices

– in vitro diagnostics

– eyeglasses

MEDICINES (ex Ministerial Decree 11.02.1997)

Definition

“Introduction into Italy of medicines regularly put on sale in foreign countries, but which are not authorized to be marketed on the national territory”.

Procedure

The attending physician, if he deems it appropriate to subject his patient to treatment with a medicine regularly authorized in a foreign country, but not in Italy, must submit a request to import the medicine to the USMAF-SASN using the following declaration of responsibility, in which one must be specified:

– name of the medicinal product, active ingredient, pharmaceutical form, daily dosage, quantity of which import is requested (for a maximum duration corresponding to ninety days of therapy/treatment);

– manufacturing company holder of the marketing authorization, specifying that the drug is regularly registered in the country of origin, specifying its name;

– that this drug is essential for patient care and therapeutic success and cannot be replaced by other drugs already registered in Italy;

– that the drug does not contain narcotic or psychotropic substances, it is not human blood and/or its derivatives;

– That the treating doctor will use the medicine under his own direct responsibility, having obtained the patient’s written informed consent (where, in turn, the description of the medicine, the patient’s personal details and his signature must be present);

– indication of the patient’s personal details, also through the use of initials or other individual code.

Warnings

– the importation is justified by objective exceptional characteristics, such as, for example, the lack of a valid therapeutic alternative, when the doctor deems it necessary to subject his patient to therapeutic treatment with a drug regularly authorized in a foreign country;

– the lack of a valid alternative can also occur when:

1. a) the drug to be imported has a different dosage of active ingredient, a different route of administration, different excipients or a different formulation of active ingredients compared to similar drugs regularly authorized in Italy,
2. b) access to the drug available in Italy is not possible for the patient, as the patient does not fall within the eligibility criteria for treatment for the provision of the medicine paid for by the NHS, or due to its excessive cost;

– the use of the medicine must take place in compliance not only with the legislation in force in Italy, but also with the conditions of use authorized in the country of origin, i.e. the medicine must be used only for the therapeutic indications for which it is registered abroad;

– the importer must schematically report the conservation methods upon arrival, with any indication of perishability and storage temperature.

Declaration of responsibility

FEATHERS AND DUVETS

– Health certificate from the country of origin complete with the analytical assessment relating to the oxygen index

– Labels

FOR PERSONAL USE

Request by the importer, dated and signed, indicating the quantity and characteristics of the goods (to be made with this form)

Module for importing goods for personal use

FOR TECHNICAL TESTS USE

If goods such as drugs, pharmacologically active raw materials or medical devices are imported for the exclusive use of technical tests on machinery and/or laboratory checks, the USMAF will not issue any certificate.

The NSIS-USMAF application automatically directs the submitter of the request to complete the notification (without payment of the tax), the request code of which must, however, be communicated via e-mail (usma.venezia.rich@sanita.it), together to the presentation of the following documentation (attached in the application, possibly in “pdf” format, using the “attach file” function):

– notification dated and signed by the freight forwarder;

– required to present, once technical tests have been carried out, the certificate of destruction, re-exportation, or storage of the imported goods.

These documents must be kept available to the Supervisory Authority for any checks and/or requests for investigations.

At the conclusion of the technical tests, both in the case of notification and issue of NOS, when the goods are subsequently destined for destruction or another type of disposal, the declaration of delivery to the appointed company must be attached to the application and dated. relevant communication to the USMAF via e-mail (as above).

– self-declaration for medical devices
– in vitro diagnostics
– eyeglasses

Definition

“Introduction into Italy of medicines regularly put on sale in foreign countries, but which are not authorized to be marketed on the national territory”.

Procedure

The attending physician, if he deems it appropriate to subject his patient to treatment with a medicine regularly authorized in a foreign country, but not in Italy, must submit a request to import the medicine to the USMAF-SASN using the following declaration of responsibility, in which one must be specified:

– name of the medicinal product, active ingredient, pharmaceutical form, daily dosage, quantity of which import is requested (for a maximum duration corresponding to ninety days of therapy/treatment);

– manufacturing company holder of the marketing authorization, specifying that the drug is regularly registered in the country of origin, specifying its name;

– that this drug is essential for patient care and therapeutic success and cannot be replaced by other drugs already registered in Italy;

– that the drug does not contain narcotic or psychotropic substances, it is not human blood and/or its derivatives;

– That the treating doctor will use the medicine under his own direct responsibility, having obtained the patient’s written informed consent (where, in turn, the description of the medicine, the patient’s personal details and his signature must be present);

– indication of the patient’s personal details, also through the use of initials or other individual code.

Warnings

– the importation is justified by objective exceptional characteristics, such as, for example, the lack of a valid therapeutic alternative, when the doctor deems it necessary to subject his patient to therapeutic treatment with a drug regularly authorized in a foreign country;

– the lack of a valid alternative can also occur when:

1. a) the drug to be imported has a different dosage of active ingredient, a different route of administration, different excipients or a different formulation of active ingredients compared to similar drugs regularly authorized in Italy,
2. b) access to the drug available in Italy is not possible for the patient, as the patient does not fall within the eligibility criteria for treatment for the provision of the medicine paid for by the NHS, or due to its excessive cost;

– the use of the medicine must take place in compliance not only with the legislation in force in Italy, but also with the conditions of use authorized in the country of origin, i.e. the medicine must be used only for the therapeutic indications for which it is registered abroad;

– the importer must schematically report the conservation methods upon arrival, with any indication of perishability and storage temperature.

Declaration of responsibility

– Health certificate from the country of origin complete with the analytical assessment relating to the oxygen index

– Labels

Request by the importer, dated and signed, indicating the quantity and characteristics of the goods (to be made with this form)

If goods such as drugs, pharmacologically active raw materials or medical devices are imported for the exclusive use of technical tests on machinery and/or laboratory checks, the USMAF will not issue any certificate.

The NSIS-USMAF application automatically directs the submitter of the request to complete the notification (without payment of the tax), the request code of which must, however, be communicated via e-mail (usma.venezia.rich@sanita.it), together to the presentation of the following documentation (attached in the application, possibly in “pdf” format, using the “attach file” function):

– notification dated and signed by the freight forwarder;

– required to present, once technical tests have been carried out, the certificate of destruction, re-exportation, or storage of the imported goods.

These documents must be kept available to the Supervisory Authority for any checks and/or requests for investigations.

At the conclusion of the technical tests, both in the case of notification and issue of NOS, when the goods are subsequently destined for destruction or another type of disposal, the declaration of delivery to the appointed company must be attached to the application and dated. relevant communication to the USMAF via e-mail (as above).