How does pharmacy inspection work?
You should know that medicines for human use, medical equipment, and cosmetics, as well as other types of goods, must go through Pharmacy Inspection before being exported or imported.
Thus, the Pharmacy Inspection is an operation carried out by the Border Inspection Service (SIF) that controls the trade, entry and exit of goods of this type.
The control of the hygienic-sanitary conditions of foreign trade is supervised by the General Directorate of Public Health, Quality, and Innovation of the Ministry of Health.
The Customs Precincts of the Functional Areas of Health dependent on the Government Delegations in the Autonomous Communities carry out the Pharmacy Inspection.
In addition, the Spanish Government Delegations and Sub delegations in the Autonomous Communities use Customs Precincts where Pharmacy inspections are carried out.
When it comes to guaranteeing the quality, safety, efficacy, and information of medicines for human use, medical devices and cosmetic products, the Spanish Agency of Medicines, and Medical Devices (AEMPS) must be mentioned.
What does a pharmacy inspector inspect?
Pharmacy examines products that are related in any way to human welfare and the consumption of products for human use.
The objective is to keep non-compliant, illegal, and counterfeit products off the market.
To meet these requirements, the Pharmacy Inspectorate must supervise the import and, in some cases, the export of the following substances:
- Drugs and medicines
- Medical devices
- Cosmetics
- Hygiene and personal care products
- Personal and clinical biocides
- Pharmaceutical raw materials used in the production of prescription drugs.
- Natural raw materials used in the manufacture of cosmetics.
- Consult the website of the Agency of Medicines and Health Products to find out which products are subject to Pharmacy Inspection (AEMPS).
What are the methods used by the pharmacy inspection?
The range of items subject to Pharmacy Inspection is diverse.
To facilitate the process of sanitary control, there is the SIFAEX application (Foreign Health Pharmaceutical Inspection Computerized System for Pharmaceutical Inspection. This depends on the AEMPS.
The sanitary controls submitted by the Economic Operators or pharmaceutical companies are carried out in more than 50,000 controls each year through the SIFAEX computer system.
With respect to sanitary controls, SIFAEX, is responsible for managing and processing 50,000 sanitary controls each year, it is used by companies that carry out import and export activities, including Authorized Economic Operators and pharmaceutical companies.
With this platform, administrative costs are reduced, making it possible to streamline customs processes, enabling the international trade of more than 12 billion euros of exports per year.
The Economic Operators are the ones who address the Pharmaceutical Inspection Service of the customs and transmit to SIFAEX, affiliated to the Organization for Economic Cooperation and Development, the Official Spanish Pharmaceutical Inspection Document (DOIFE).
To prevent people from smuggling illegal pharmaceutical products through customs, the customs office discloses in advance the pharmacological control to which the products would be exposed.
The pharmacological controls to which pharmaceutical products are subjected by the customs office are as follows:
- Documentary control: commercial, transport and technical documents.
- Identity control: control of health certificates and documents, as well as marking and labeling.
- Physical condition control: control of labeling, packaging, and other physical conditions of the product.
Control documentation is always necessary. Physical controls are used to ensure the safety of the product, as well as the results of documentary controls carried out as part of the documentary approach to risk management.
Where are pharmacy inspection controls carried out?
Pharmacy Inspection controls are carried out in customs enclosures, which are usually located in the main ports and airports of the country.
The EU authorizes BIPs (Border Inspection Posts) for the documentary and physical control of all goods subject to Pharmacy Inspection.
The airports with the highest volume of cargo, such as Madrid-Barajas and Barcelona-El Prat, use all the BIPs.
The ports of Barcelona, Algeciras, Valencia, and Bilbao are some of the most significant.
Are you interested in scheluding an inspection of your pharmacy?
Customs processes are one of our specialties at Connecta. So that there is no risk involved, we can provide you with assistance in procuring or shipping any type of pharmaceutical and healthcare goods.
Not only are we able to help your business with Pharmacy Inspection, but we can also make it fast, easy, and affordable for you.
As we are an Economic Operator, we can handle your pharmaceutical control request through SIFAEX.
Our team of experienced experts is ready to assist you throughout the entire pharmacy inspection process.
Connecta has two channels of communication and document transmission:
– By email to: info@miconnecta.com
– You can also use our Connect with us form.
