When a shampoo is sold at a drug store, this is normal. However, when the beauty shop sells medicinal products, this is a violation of law. In some cases, this is a real crime.
There is a very big attraction is selling and buying preparations and products that are used in medical practice and in some manner have an impact on the functioning of a human body (that is, the products that are categorized as medical-purpose goods). Of course, we are talking not about the special prescription preparations or about the equipment, to operate which, special knowledge and skills are required.
We are talking about “simple” things, for example, when the buyer in the drug store window next to the lash mascara may see headache pills, and next to a nail grooming kit, iodine or hydrogen peroxide, while next to the sun-eyeglasses they may see a solution for storing contact lenses, etc.
Is it legal?
With the advent of the digital era, many goods “moved” from traditional stores to the Internet. However, the rules that cover special kinds of products (in particular, medical-purpose goods) not only continue to apply but have become stricter.
What should the vendor know before taking up medical-purpose goods for sale?
What should the user know before buying such goods in an online store?
Let us grapple with this task!
The legal status of medical-purpose goods:
In Ukraine, to Registers apply to “medical” goods in a broad sense:
· The State Register of Medical Equipment and Medical-Purpose Products.
· Register of Medicinal Products.
Medical-purpose products (medicinal products) shall mean any tool, instrument, device, software, material or other product intended for diagnosing, treating, and preventing diseases in human body or for supporting such processes.
Medicinal product shall mean a substance or a combination of substances that is intended for treatment or prevention of diseases in people, restoration, correction or change of physiological functions of humans by means of a pharmacological, immunological or metabolic action as well as for the establishment of a medical diagnosis.
If both are commodities from the commercial point of view, medicinal products and pharmaceutical products have many differences.
The goods in the category of medical items (tools, devices, instruments etc.) are not subject to licensing. It means that if you decide to take up the sale of arterial tension measurement devices, you may do so by simply following the laws of electronic commerce.
However, all the goods (and actions with respect to them) that are categorized as medicines are subject to licensing.
This means the following:
- manufacture of medicinal products;
- wholesale and retail trade in medicines;
- importation of medicinal products; and
- medical practice;
Let us imagine that you are selling contact lenses and spectacle frames, It means medical products.
Can you do it without a license?
Yes, you can.
However, if along with lenses and frames you sell medicines (for example, eye drops) or make diagnosis of patients’ eyesight for writing a prescription of eyeglasses, you would need to secure a license. Otherwise, you activities will be illegal.
An online sale of medical devices is allowed on general grounds.
An online sale of medicines shall be allowed only subject to meeting the following conditions:
• the availability of a license;
• the availability in the special register;
• the availability of an own delivery service or a contract for delivery services concluded with a special service;
• an online consultation of a pharmacist;
• the ensuring of a proper storage and transportation of medicines;
• prescription medicines shall be sold only on prescription;
• the sale of narcotics, powerful and radioactive preparations etc. shall be prohibited.
What things does the user need to pay attention to when buying medical-purpose goods?
It is very convenient, to buy goods online. However, if your health is at stake, when you are visiting an online store, pay attention to the following:
1. If you are buying medicines, make sure the vendor has a license.
3. Read the Public Offer document. This is another “must-have” document of an online store. The Public Offer document (aside from general provisions, subject of contract, ordering options, price and payment terms, terms of delivery and return of the goods, the rights and obligation of the vendor and the buyer, force majeure and other provisions) shall set forth information about the business entity providing the services (the name, registration and contact information).
This document shall have detailed information about the procedure for changing and retuning the goods or a notice that the “goods cannot be returned.”
Aside from that, the Public Offer document should contain a description of the terms for the interaction between the users and third-party services (for example, payments using payment services providers and authentication using social networking websites).
Please, pay attention to the section dedicated to setting up a user account. Do you understand the rules of using the user account? Do you understand the manner in which responsibility would be divided between you and the vendor for the use of the personal account?
4. Carefully read the Disclaimer document. It would be better to do so before purchasing.
5. Make sure that all of the above documents are posted on the website in a prominent place, that they are written in plain language and that you understand them.
6. Carefully review the text of the Public Offer and, if you disagree with any item, you have the right to forgo the purchase of the goods/services that are sold at that online store.
When making purchases online, it is a rare occasion that we take time to read legal documents posted on the website. This is a mistake.
When buying some product, you should know what will happen to your personal data, whether the vendor is entitled to offer this product to you, and in which cases the store owner will not bear responsibility, etc.
However, if you are buying not just “some product” but a medical-purpose product, it would pay to spend five minutes reading legal documents rather than cause harm to one’s own health.