Last year it resolved 8 sanctioning proceedings worth 166,500 euros.
The Inspection Service of the Directorate General for Services and Pharmacies, part of the Regional Ministry of Health and Consumer Affairs, carried out a total of 243 inspections last year – the total number of inspections planned – which means that the level of compliance reached 100%. As a result of these inspections, a total of 166,500 euros in penalties were imposed in the area of medicines and health products in 2021.
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166,500 in penalties for medicines and medical devices in 2021. These correspond to 7 cases that were initiated and resolved last year (for a total of 136,500 euros), while a further case (30,000 euros) was opened at the end of 2020 and finalised in January 2021. In addition, of the total amount, 147,500 euros correspond to penalties for cases where early reduced payment was requested. The sanctions were imposed for breaches of pharmacy and medical device regulations, as well as for health deficiencies detected by inspectors from the Directorate General of Benefits and Pharmacy.
In addition, up to 15 proceedings were initiated in 2021, of which seven were resolved in the course of the year. The rest are still being processed and are expected to be resolved as soon as possible.
By type of establishment, they are distributed as follows:
- Pharmacies: 155.
- Customised manufacturers of medical devices: 9.
- Sales of medical devices without adaptation: 18.
- Retailers of veterinary medicinal products: 3.
- Foreign clinics: 9.
- Veterinary clinics: 25.
- Distributors of medicinal products: 4.
- Pharmaceutical laboratories: 3.
- Socio-health centres: 12.
- Other types of establishments: 5.
To carry out these inspections, protocols adapted to each type of establishment are applied. These protocols are drawn up, modified or adapted periodically, with the aim of adapting them to changes in regulations, the critical points of inspections to be carried out annually or the need to collect information data. As a novelty, during the year 2021 an inspection plan was implemented for medicine cabinets in these establishments to check whether they were in line with current regulations, as they are obliged to inform the Administration of the possession of veterinary medicines in their centre.
Inspections have also been carried out in social healthcare centres with fewer than 100 beds, where the management of medicines in the centre has been checked and their medicine stores have been linked to a pharmacy in the same pharmaceutical area with the aim of improving pharmaceutical care for residents.
Overall inspection plan 2021
In 2021, the Inspection Service of the Directorate General for Benefits and Pharmacies carried out a total of 243 inspections – the total number of inspections planned – so the degree of compliance reached 100%. By type of establishment, they are distributed as follows:
- Pharmacies: 155.
- Customised manufacturers of medical devices: 9.
- Sales of medical devices without adaptation: 18.
- Retailers of veterinary medicinal products: 3.
- Foreign clinics: 9.
- Veterinary clinics: 25.
- Distributors of medicinal products: 4.
- Pharmaceutical laboratories: 3.
- Socio-health centres: 12.
- Other types of establishments: 5.