Agenzia why not

Bis 2- 2-methoxyethoxy ethyl ether. Dibutylbis pentane-2,4-dionato-O,O' tin. Butyl 4-hydroxybenzoate. Perfluorobutane sulfonic acid PFBS and its salts. Diisohexyl phthalate. Phenol, 4-nonyl-, phosphite EC No. Terphenyl, hydrogenated.

Disodium octaborate. Dicyclohexyl phthalate. Benzene-1,2,4-tricarboxylic acid 1,2 anhydride. Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear RP-HP.

Formaldehyde, reaction products with branched and linear heptylphenol, carbon disulfide and hydrazine EC No.

Cadmium nitrate. Specific target organ toxicity after repeated exposure Article 57 f - human health. Cadmium hydroxide. Cadmium carbonate. Perfluorohexanesulphonic acid and its salts. Nonadecafluorodecanoic acid PFDA and its sodium and ammonium salts. Nonadecafluorodecanoic acid EC No.

Toxic for reproduction Article 57c Endocrine disrupting properties Article 57 f - environment Endocrine disrupting properties Article 57 f - human health. Endocrine disrupting properties Article 57 f - environment Endocrine disrupting properties Article 57 f - human health.

Carcinogenic Article 57a Equivalent level of concern having probable serious effects to human health Article 57 f - human health Equivalent level of concern having probable serious effects to the environment Article 57 f - environment. Equivalent level of concern having probable serious effects to human health Article 57 f - human health Equivalent level of concern having probable serious effects to the environment Article 57 f - environment. Octamethylcyclotetrasiloxane D4.

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That action was dismissed in a judgment of 13 January In its defence, the AIFA argues, amongst other matters, that Avastin is not prepared industrially for use in eyes. Moreover, the Italian Republic is entitled to avail itself of the power under Article 5 1 of that directive to derogate from its provisions. In any event, the AIFA submits, first, that the main proceedings do not concern the placing on the market of a medicinal product, only its use off label.

Secondly, under the second subparagraph of Article 40 2 of that directive the process in question can be carried out without a manufacturing authorisation. In those circumstances, the Consiglio di Stato Council of State decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:.

The first and second questions referred. Preliminary observations. According to that court, that reimbursability encourages off-label uses, regardless of the therapeutic needs of each patient.

According to that article, medicinal products cannot be placed on the market in the Member States unless an MA has previously been obtained for them. When an initial MA has been granted for a medicinal product, any addition or variation relating in particular to the strength, route of administration, presentation or therapeutic indications must be covered by a new MA or be added to the initial MA.

It should be noted in that regard that, under Article 7 TFEU, the organisation and management of health services and the allocation of the resources assigned to them are the responsibility of the Member States. As the case-law shows, the Member States also still have powers not only to regulate the reimbursement of medicinal products in order to promote the financial stability of their healthcare insurance schemes, 12 but to regulate the conditions under which doctors can prescribe those products.

Nevertheless, the Court of Justice has repeatedly held that the Member States must exercise their powers in compliance with EU law.

A Member State, unless it is to deprive those rules of effectiveness, cannot, through its medicines reimbursement policy, condone the placing on the market or manufacture of medicinal products where those products do not have the authorisations required under those rules.

I note, in that respect, that the AIFA decisions relate to the medicinal products resulting from the repackaging of vials of Avastin, by pharmacies that comply with the conditions laid down by those decisions, into several syringes containing only the dose necessary for an intravitreal injection, that are then delivered to hospitals where their contents are subsequently administered to patients.

In the event that those requirements were not satisfied in the present case, it would be necessary, thirdly, to examine whether the Member State in question is nevertheless entitled to derogate from them under Article 5 1 of that directive see section 4 below.

The Novartis Farma judgment 18 has already more than adequately outlined the reasoning needed to answer those questions. The factual context of that case can nevertheless be distinguished from the dispute in the main proceedings in so far as that case concerned the repackaging of Avastin by a company which then delivered the resulting individual doses to the pharmacies that had ordered them.

The situation at issue in the present case, on the other hand, concerns the repackaging of Avastin by pharmacies to be supplied to hospitals. It also asks the Court of Justice what is the effect, in that context, of the fact that the medicinal product is administered in a facility other than that where those processes took place.

To my mind, how that question should be answered depends primarily on whether or not the product obtained as a result of removing Avastin from its original file and transferring it into several single-use syringes for use in ophthalmology should be regarded, for the purposes of applying that directive, as a different medicinal product from the medicinal product Avastin, developed by the Roche group and covered by an MA for therapeutic indications for cancer.

I note, in that respect, that preparing Avastin to treat AMD involves modifications relating to the strength, packaging and route of administration of that medicinal product. On the other hand, neither the order for reference nor the case file submitted to the Court indicates that preparing it in that way affects the medicinal substance itself.

On the contrary, the AIFA decisions merely allow Avastin to be repackaged in single doses, under conditions intended to ensure sterility. The Court of Justice left it to the national court to ascertain whether those conditions were satisfied, 24 in the light of the fact that, in its order for reference, that court had proceeded on the basis that the dividing up and repackaging of Avastin did not modify its composition.

The premiss underlying that approach, it seems to me, was that, provided the medicinal substance itself is not thereby altered, the changes to the strength, packaging and route of administration of Avastin so that it can be used off label do not give rise to the creation of a different medicinal product for the purposes of applying EU pharmaceutical rules. Accordingly, that product is still, amongst other matters, subject to the pharmacovigilance system established in that directive.

As Ireland submits in essence, wherever a medicinal product falls within the scope of that directive, all the processes it undergoes — including its initial manufacture, placing on the market and, where applicable, subsequent processes to divide up and repackage the product — are governed by that directive.

The same applies, I submit, even where the processes to divide up and repackage the product in question, taken in isolation, are not industrial and are carried out by pharmacies on the basis of individual prescriptions.

They are therefore relevant to determining whether the pharmacies must have, on the one hand, a manufacturing authorisation under Article 40 1 of that directive in order to repackage a vial of Avastin into several single-use dose syringes and, on the other hand, an MA under Article 6 1 of that directive in order to supply those syringes to hospitals. For the sake of completeness, I would add that, conversely, if the pharmacies performed processes on an existing medicinal product covered by an MA which did modify the medicinal substance of that product, 30 the resulting product would have to be regarded as a new medicinal product for the purposes of applying EU pharmaceutical rules.

In the Abcur judgment, 31 the Court of Justice held that for that article to apply, it is necessary only that the conditions expressly provided for in it are met. It must therefore be prepared specifically for a previously identified patient. Incidentally, the Court did not require the prescriptions to be customised for each patient according to different therapeutic needs. Requirements relating to placing on the market and manufacture. It is apparent from the order for reference that the pharmacies that repackage vials of Avastin in individual syringes and supply them to hospitals do not hold an MA for that purpose.

Neither the treatment of AMD, nor the strength, route of administration and presentation required for that therapeutic indication are covered either by the MA for Avastin held by the Roche group or by any new MAs those pharmacies may have obtained. As I described above, the Court of Justice has already established, in Novartis Farma , 33 that a company could divide up and repackage vials of Avastin and supply pharmacies with the resulting single-use syringes without previously obtaining an MA, provided the dividing up and repackaging, first of all, do not lead to any modification of the medicinal product and secondly, are carried out on the basis of individual prescriptions.

The first of the conditions set out in that judgment and already examined above, appears to be satisfied in the present case. Indeed, the Court did not find that the fact that the company in question in that case batch produced standardised doses of Avastin for use in eyes prevented that condition from being satisfied. In the present case, under the AIFA decisions, the Avastin must be divided up and repackaged by none other than hospital pharmacies.

Accordingly, the activity of the pharmacies authorised to do so by the AIFA decisions, consisting of dividing up and repackaging vials of Avastin on the basis of individual medical prescriptions, without thereby altering the medicinal substance, and then supplying the individual doses resulting from those processes to hospitals which will administer them to patients, does not require an MA to be obtained.

Accordingly, it is necessary to examine whether the dividing up and repackaging of Avastin require a manufacturing authorisation under Article 40 1 of that directive. Although the referring court did not mention that article in the wording of its questions, that examination does appear necessary in order to provide that court with an answer of use to it. Under the first subparagraph of Article 40 2 of that directive, that authorisation is required for both total and partial manufacture, and for the processes of dividing up, packaging or presentation of medicinal products which may take place, as in the present case, after the product in question has been placed on the market.

In particular, the manufacturer in question must make an application and supply a range of information in support of it. Assuming that the referring court confirms that the pharmacies authorised to divide up and repackage Avastin under the AIFA decisions do not hold manufacturing authorisations, those processes can nevertheless, in my view, fall within the exemption under the second subparagraph of Article 40 2 of that directive.