TEMBLOR DE REPOSO EN MMSS Ausente.

This form is used by any organisation or company when they want to import samples of animal products for purpose of diagnostic, research etc. Within the four sectors of this study, the form will typically be used in pharmaceutical companies by their laboratories and research units, but it may also be necessary for companies who want to import small samples of food products of animal origin for trade, testing or evaluation.

The form details the type of product which will be imported, what it was derived from, how it will be transported, where it was produced etc. It is a condition of the licence that the product may not be placed on the market and must be destroyed to the satisfaction of the Department of Agriculture, Fisheries and Food following the purpose of import. The application for an import license should be accompanied by an invoice from the company where the product is imported from.

The regulation related to this requirement is handled by the Department for Agriculture, Fisheries and Food.

Administrative activities in companies

45_{Please note that there may be discrepancies in the total administrative costs figure for all filings. This} is due to the rounding that has been applied in this text on the per registration/filing figure.

In order to apply for the license, companies fill out the form and send it to the Department of Agriculture, Fisheries and Food along with a copy of the invoice from the company from where the product will be purchased.

It has only been possible to interview one pharmaceutical company who had experience with filing this form, and they estimated that they spent around 5 hours per filing. Most of the work was carried out by clerical staff, but the information was checked by a manager before it was submitted, and the manager also signed the form. The following administrative activities were involved in filling out the form:

 Information retrieval (25% of time);  Assessment (15% of time);

 Checking (10% of time – done by manager);  Text description (25% of time);

 Internal meetings (15% of time);

 Reporting/submitting information (10% of time). There were no external costs involved in filing the form.

Number of iterations

In 2007 a total of 382 import licenses where issued by the Department of Agriculture, Fisheries and Food in relation to VET 15. This information comes from the Department of Agriculture, Fisheries and Food.

Administrative costs

The total administrative costs of filing the VET 15 form are as follows:  Per application €129.02

 In total for all filings €49,28746

All of these administrative costs are due to Irish requirements.

VET 16: Import license for Carcases and Animal Products

(Prohibition) etc.

This form is used in cases of import of certain animal by-products to be used in manufacture where EU harmonised veterinary import rules have not yet been designated. Importers, principally pharmaceutical companies, use these products for the manufacture of diagnostic or research equipment or pharmaceuticals.

46_{Please note that there may be discrepancies in the total administrative costs figure for all filings. This} is due to the rounding that has been applied in this text on the per registration/filing figure.

The form details the type of product which will be imported, what it was derived from, how it will be transported, where it was produced etc. The application for import license should be accompanied by an invoice from the company where the product is imported from together with a copy of the appropriate format of health certificate. The regulation related to this requirement is handled by the Department for Agriculture, Fisheries and Food.

Cases where this import licence is required are also required under EU rules to be submitted for veterinary checks at an approved Border Inspection Post (BIP). This is undertaken when the material enters on to the territory of the EU and must be carried out before it can be cleared by Customs. Thus, in addition to completing the VET 16 procedure and submitting the import licence to the BIP, the importer will have to follow the CVED requirements outlined above.

Administrative activities in companies

In order to apply for the license, companies fill out the form and send it to the Department of Agriculture, Fisheries and Food along with a copy of an invoice from the company from where the product will be purchased, and other relevant certificates, e.g. health certificates and certificates of analysis.

It has only been possible to interview one pharmaceutical company who had experience with filing this form, and they estimated that they spent around 5 hours per filing. Most of the work was carried out by clerical staff, but the information was checked by a manager before it was submitted, and the manager also signed the form. The following administrative activities were involved in filling out the form:

 Information retrieval (25% of time);  Assessment (15% of time);

 Checking (10% of time – done by manager);  Text description (25% of time);

 Internal meetings (15% of time);

 Reporting/submitting information (10% of time). There were no external costs involved in filing the form.

One element of this form caused considerable annoyance to the interviewed company. In some cases, the EU and the US authorities have different opinions on how animal products should be classified, and therefore the terms under which they are to be produced. Therefore, a product may be produced under certain conditions in the US, while these conditions are not immediately recognised by the EU. Hence, a company importing such products from the US will have to spend considerable time obtaining documentation from the US-company, clarifying the conditions under which the product has been produced.

In 2007 a total of 133 import licenses where issued by the Department of Agriculture, Fisheries and Food in relation to VET 16. This information comes from the Department of Agriculture, Fisheries and Food.

Administrative costs

The total administrative costs of obtaining an import license are as follows:

 Per import license €129.02

 In total for all import licenses €17,160

All of these administrative costs are due to Irish requirements.47