Update on article 'Belgian law prohibits free sale [...]'

Summary

From our network we have learned of Belgian legislation imposing restrictions on the free sale of certain medical products. At ProductIP we see a lot of local emergency product legislation with short duration dates. Should you have information on local legislation that applies to 'COVID-19-products', please let us know so that we can inform the entire industry. 

Content

UPDATE

The Belgian government has published a new decision, lifting the previous measures that only permitted by licensed pharmacies are permitted to sell certain medical devices (link to the decision). In short: sale of surgical masks, hydroalcoholic gels and hand alcohol is again permitted. 

Updated decision

As of 23-3-2020, for the duration of 3 months, the retail sale of the following medical devices is only permitted by licensed pharmacies insofar as they are prescribed by a healthcare professional:

1. surgical masks; [update: permitted as of 04-05-2020]
2. screening material;
3. disinfection wipes for medical use;
4. respirators and related equipment and accessories:
5. single-use cuffs for blood pressure measurement;
6. self-adhesive ECG electrodes;
7. devices used for bronchoalveolar lavage;
8. single-use inhalation chambers and masks bronchoscopes.

Registered distributors shall only sell the medical devices referred to:

• other registered distributors in the products concerned;
• licensed pharmacies;
• hospitals;
• authorised healthcare professionals.

As of 23-3-2020, for the duration of 3 months, the retail sale of the following personal protective equipment and biocides is only permitted by licensed pharmacists if prescribed by a health care professional:

1. FFP2 masks;
2. FFP3 masks;
3. hydroalcoholic gels; [update: permitted as of 09-05-2020]
4. permeable or non-permeable protective gels;
5. protective goggles and masks;
6. gloves (nitrile) long sleeve at least 300mm;
7. hand alcohol; [update: permitted as of 09-05-2020]
8. hydrogen peroxide 12% and nebulisers (nocospray).

The wholesalers shall only sell the personal protective equipment and biocides referred to in the first paragraph:

• wholesalers in the products concerned;
• licensed pharmacies;
• hospitals;
• authorised health professionals;
• companies that need them within the framework of Book 9, Title 2 of the Codex on well-being at work, and in volumes reasonably foreseeable for use within the next month.

As of 09-04-2020, Manufacturers and wholesalers may sell the products referred to in the first paragraph to companies which need these products by or by virtue of statutory or regulatory provisions, other than those relating to the protection of their employees, in the manufacture, processing, storage or warehousing of their goods or in the exercise of their activities.

Original decision

As of 23-3-2020, for the duration of 3 months, the retail sale of the following medical devices is only permitted by licensed pharmacies insofar as they are prescribed by a healthcare professional:

1. surgical masks;
2. screening material;
3. disinfection wipes for medical use;
4. respirators and related equipment and accessories:
5. single-use cuffs for blood pressure measurement;
6. self-adhesive ECG electrodes;
7. devices used for bronchoalveolar lavage;
8. single-use inhalation chambers and masks bronchoscopes.

Registered distributors shall only sell the medical devices referred to:

• other registered distributors in the products concerned;
• licensed pharmacies;
• hospitals;
• authorised healthcare professionals.

As of 23-3-2020, for the duration of 3 months, the retail sale of the following personal protective equipment and biocides is only permitted by licensed pharmacists if prescribed by a health care professional:

1. FFP2 masks;
2. FFP3 masks;
3. hydroalcoholic gels ;
4. permeable or non-permeable protective gels;
5. protective goggles and masks;
6. gloves (nitrile) long sleeve at least 300mm;
7. hand alcohol;
8. hydrogen peroxide 12% and nebulisers (nocospray).

The wholesalers shall only sell the personal protective equipment and biocides referred to in the first paragraph:

• wholesalers in the products concerned;
• licensed pharmacies;
• hospitals;
• authorised health professionals;
• companies that need them within the framework of Book 9, Title 2 of the Codex on well-being at work, and in volumes reasonably foreseeable for use within the next month.