Intermediate Products

1. An intermediate product is defined, in Annex I of Regulation (EU) 142/2011, as a derived product which is intended for uses within the manufacturing of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products as follows:

i. As material in a manufacturing process or in the final production of a finished product

ii. In validation or verification during a manufacturing process; or

iii. In quality control of a finished product

2. An intermediate product’s design, transformation and manufacturing stages must have been sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for the purposes referred to in point 1.

3. An intermediate product, however, requires some further manufacturing or transformation, such as mixing, coating, assembling or packaging to make it suitable for placing on the market or putting into service, as applicable, a medicinal product, veterinary medicinal product, medical device for medical and veterinary purposes, active implantable medical device, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagent or cosmetic products.

4. Intermediate products must be produced and stored in accordance with the requirements of Annex XII of Regulation (EU) 142/2011.

5. An intermediate product can be imported provided that it:

i. Comes from an approved country/part of a country

ii. Comes from an approved establishment

iii. Is accompanied by and conforms with the requirements of an agreed declaration document

1. Intermediate products may only be imported from a Third Country, according to Article 1(d) in Annex XII of Regulation (EU) No 142/2011, listed as a member of the World Organisation for Animal Health (OIE) in the OIE bulletin:

• See list here

2. Intermediate products must be produced in establishments approved to export to the EU. These establishments must be registered or approved by the competent authority in the Third Country in accordance with Article 23 of Regulation (EC) No. 1069/2009. Further requirements may be found in Article 2 in Annex XII of Regulation (EU) No 142/2011.

• See list here

3. According to Annex XII of Regulation (EU) No 142/2011 the import and transit of intermediate products shall be authorised, provided that:

a. They are derived from:

i. Category 3 material, other than materials referred to in Article 10(c), (n), (o) and (p) of Regulation (EC) No 1069/2009

ii. products generated by the animals referred to in Article 10(i), (l) and (m) of Regulation (EC) No 1069/2009

iii. mixtures of the materials referred to in points (i) and (ii);

b. In the case of intermediate products destined for the production of medical devices, in vitro diagnostic medical devices and laboratory reagents, they are derived from:

i. Materials which fulfil the criteria referred to in point (a) except that they may have originated from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;

ii. Category 2 material referred to in Article 9(f) and (h) of Regulation (EC) No 1069/2009;

iii. Mixtures of the materials referred to in points (i) and (ii).

c. Intermediate products may only be imported if the DAFM considers the use of such materials justified for the protection of public or animal health.

d. In the case of materials referred to in point (b), the importer demonstrates to DAFM that the materials

i. Do not carry any risk of transmission of a disease transmissible to humans or animals, or

ii. Are transported under conditions which prevent the transmission of any diseases communicable to humans or animals.

4. Intermediate products must have a label on the outer packaging, bearing the words ‘for medicinal products/veterinary medicinal products/medical devices/active implantable medical devices/in vitro diagnostic medical devices/laboratory reagents only’, as per Chapter II Article 2 (xiv) of Regulation (EU) No 142/2011.

5. Intermediate products must be transported to either

i. A registered establishment or plant for the production of laboratory reagents, medical devices and in vitro diagnostic medical devices for veterinary purposes or the derived products referred to in Article 33 of Regulation (EC) No. 1069/2009, where the intermediate products must be further mixed, used for coating, assembled or packaged before they are placed on the market or put into services in accordance with the Union legislation applicable to the derived product; or

ii. An establishment or plant which has been approved for the storage of animal by-products in accordance with Article 24(1)(i) of Regulation (EC) No. 1069/2009, from where they must only be dispatched to an establishment or plant referred to in (i) of this point for the uses mentioned therein.

6. The official veterinarian at the border inspection post concerned shall inform the authority in charge of the establishment or plant at the place of destination of the consignment by means of the TRACES system.

1. The consignment of intermediate products must be presented at the Border Control Post (BCP) accompanied by a declaration of the importer in accordance with the model declaration set out in Chapter 20 of Annex XV of Regulation (EU) No 142/2011 which must be in at least one of the official languages of the EU Member State of the BIP of inspection and of the Member State of destination.

Chapter 20 Declaration for Intermediate Products

1. Consignments of intermediate products entering the EU must be inspected at an EU-approved Border Control Post (BCP) where Member States' official veterinarians ensure they fulfil all the requirements provided for in the EU legislation.

2. The person responsible for the load being imported (the importer or a customs agent acting on their behalf) must give the BCP at the intended point of entry advance notification of the arrival of the consignment.

3. There is a required minimum pre-notification notice period of at least 24 hours’ notice in advance of the consignment’s arrival.

4. Failure to submit correct documentation within this timeline may result in significant delays in the consignment being processed through the Border Control Post.

5. Pre-notification is given by the submission of Part 1 of the Common Health Entry Document (CHED-P), as is laid down in Commission Implementing Regulation (EC) No. 2019/1715, through the online TRACES system.

6. Copies of other supporting documentation associated with the consignment should be submitted at this time as well - such as the Declaration Document, Invoice, Packing list etc.

7. Please note that in addition to the TRACES online system. If you want to import or export animals, animal products or intermediate products you must also register with the Department of Agriculture, Food and the Marine. Please register using the link below.

How to register with the Department of Agriculture, Food and Marine

https://www.gov.ie/en/publication/6d8a1-registration/#how-to-register-with-the-department-of-agriculture-food-and-the-marine

1. Providing all the documentation has been submitted correctly and within the correct time frames, a large proportion of the documentary check can be commenced in advance of the consignment’s arrival.

a. Please note the original hard copy of the Chapter 20 Declaration Document must travel with the consignment, and will be checked and held at the BCP at the point of entry into the EU.

2. Provided all is in order with the documentary check, the consignment will then be subject to an identity check at the BCP to ensure it identifies with the consignment that was declared in the documentation.

3. A proportion of consignments will be selected for a full physical inspection with/without sampling as appropriate.

4. Upon satisfactory completion of the required checks, the decision is entered in Part 2 of the CHED which must accompany the consignment to the first place of destination referred to in the CHED.

5. If the consignment does not meet the import requirements, the consignment may be rejected and either re-exported or destroyed.

The intermediate products imported into the Union must be transported directly from the Border Control Post to either to:

(a) a registered establishment or plant for the production of laboratory reagents, medical devices and in vitro diagnostic medical devices or the derived products referred to in Article 33 of Regulation (EC) No 1069/2009, where the intermediate products must be further mixed, used for coating, assembled or packaged before they are placed on the market or put into services in accordance with the Union legislation applicable to the derived product

(b) to an establishment or plant which has been approved for the storage of animal by-products in accordance with Article 24(1)(i) of Regulation (EC) No 1069/2009, from where they must only be dispatched to an establishment or plant referred to at point (a) above for the uses referred to in (a).

The establishment or plant of destination of intermediate products into Ireland must be registered or approved with:

The operator or owner of the establishment or plant of destination or his representative shall keep records in accordance with Article 22 of Regulation (EC) No 1069/2009 and shall provide the competent authority on request with the necessary details of purchases, sales, uses, stocks and disposals of surplus of the intermediate products for the purposes of checking compliance with this Regulation.

The competent authority shall carry out documentary checks at regular intervals for the purpose of reconciliation of the quantities of intermediate products imported on the one hand, and stocked, used, dispatched or disposed of on the other, in order to check compliance with this Regulation.