Can you ship medical devices internationally?

Medicines can be sent by parcel

For exports of products of poultry origin destined for human consumption, the transitional procedure below will apply, together with the model declaration to be attached to the export certificate applications submitted to CEXGAN.

The export of live animals, animal products, products for human food or animal feed and sanitary products usually requires the presentation of a veterinary export certificate to the authorities of the importing country.

When they want to export, operators should consult the requirements demanded by the importing country: if there is an agreement to export that merchandise, if the establishment must be previously authorized by the importing country and what type of certificate is required by the third country for the product to be exported; in addition, it will be verified that the merchandise meets all the requirements demanded in the certificate.

How are medicines and medical devices regulated in Spain?

All drugs used in Spain must have a marketing authorization granted by the AEMPS once their quality, safety and efficacy have been favorably evaluated, and any variation must also be authorized or notified to the AEMPS.

How to import medicines into Spain?

In order to import medical devices from third countries, a sanitary license issued by the Spanish Agency of Medicines and Medical Devices (AEMPS), under the Ministry of Health, is required. This license complies with the current legislation for the importation of medical devices.

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How is the quality and safety of a drug guaranteed?

To guarantee the quality of a drug it is not enough to maintain a good control of the identity, titration and purity (active ingredient, concentration), it is also necessary to take into account other factors that may affect its bioequivalence, good manufacturing practices, the quality of the excipients …

Invima approval for importation

The action of exporting products from Mexico to the United States is an excellent decision for those who seek the growth of their company; however, it is always necessary to have a foreign trade strategy, the support of a customs broker, as well as good security measures for the transportation of your goods.

The classification of the merchandise is essential to determine the type of product, tax and packaging requirements to which it is subject. During the process, you should consider the following points:

Returning to the security part of the goods, during transportation, whether by land or sea, it is advisable to use tax stamps, as they are the right ones to successfully pass the control filters at the border with the United States.

At Interseal we have tax seals that guarantee maximum security in the transfer of your goods to the United States, and also guarantee the successful passage to the border, as they are certified under the ISO 17712:2013 standard and the tax seals authorized by the SAT.

Who regulates medicines?

(FDA) reviews, evaluates and approves a wide range of products for medical use, including drugs, medical devices, foods, cosmetics and many other health-related products.

Which agencies regulate the use of drugs in humans?

The State Agency of Medicines and Health Technologies – AGEMED is created, responsible for regulating the activities carried out by natural and legal, private, community, public, mixed and cooperative persons in the medicines and health technologies sector.

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How to obtain an import license for medical devices?

In order to obtain the import license in Spain, it will be necessary to accredit the state of the sanitary facilities or warehouses and to have a technical manager. The figure of the technical responsible is necessary to be able to guarantee the safety in its storage and distribution.

It is possible to send medicines by mail to the United States.

The rewritten text of Law 29/2006, of 26 July, on guarantees and rational use of medicines and health products, approved by Royal Legislative Decree 1/2015 of 24 July, dedicates its title V, articles 72 and 73, to the health guarantees of foreign trade of medicines.

The regulation of these guarantees has been developed by Chapter VIII of Royal Decree 824/2010, of June 25, which regulates pharmaceutical laboratories, manufacturers of active ingredients for pharmaceutical use and foreign trade of medicines and medicines under investigation, which establishes the conditions for the import, manufacture and export of medicines destined for foreign trade.

Advanced therapy drugs do not have any special classification and therefore their processing will be carried out as any other registered drug, investigational drug intended for clinical trial or in special situation.

As of July 2, 2013, active ingredients intended for the manufacture of medicinal products for human use may only be imported if they have been manufactured in accordance with Good Manufacturing Practice (GMP) standards at least equivalent to those established by the EU and in addition:

What taxes are paid to export to the United States?

The tax paid on the import of goods is known as: General Import Tax (IGI) and the tax paid on exports is the General Export Tax (IGE), generally exports are exempt from the payment of the latter tax.

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What is done in drug quality control?

Quality Control is the entity in charge of performing all the analyses to establish whether the drug complies with the legal requirements declared by each company and with the parameters that pharmaceutical products must comply with, as indicated in the specifications.

What is the quality control regulator for healthcare products?

At the National Administration of Medicines, Food and Medical Technology, we protect the population by ensuring that health products are effective, safe and of high quality.

How to send medicines abroad

Disposable or reusable face masks that protect against particulate hazards, disposable or reusable coveralls, gloves and protective goggles, all of which are used for prevention and protection against harmful biological agents, such as viruses, are products that fall under the scope of Regulation (EU) 2016/425.

With regard to the export of this material, new restrictions implemented by the European Commission due to the substantial increase in demand for medical protective equipment must be taken into account.