Requirements to open a drugstore in Colombia: Norms

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Drug store or pharmacy? know the Requirements to open a drugstore in Colombia: Norms, there is no major difference in this type of commercial establishment beyond their names.

Colombian laws establish regulations for the opening and operations of the drugstore, below we will comment on this profitable business.

What is a drugstore

The drugstore owes its origin to the term “Droga”, which is how they referred in ancient times to dried medicinal plants that produced unknown side effects.

Today it is called a drugstore commercial establishment, where medicines or drugs are sold, necessary in certain treatments to regain health and that have been indicated by a doctor.

Where in addition to marketing medicines, we find personal hygiene and cleaning products.

Also other products related to the cosmetic area. In Latin America they are also called a pharmacy.

Expanding a little further, the word “Drug” is originally from the Dutch “droog”. Referring to the dried plants that at the end of the 16th century, Dutch merchants transported from the communities in Asia. And they caused them side effects and novel for the time.

The term Dutch reached European languages ​​some time after the word “drogue” was accepted in France to refer to dry products in barrels. This was the way the dried plants were transported.

During the Renaissance, any product was marketed in places known as apothecaries.

These were like a supply where they sold everything. As time went by, the pharmacies became specialized in medicinal preparations.

Grocery stores were created, offering food products and some Asian and American products.

And in the places where they sold dry cosmetic products, they were called “drugstores”.

Finding in them products such as powders to whiten the face, give color to the cheeks and beautify the eyes.

These establishments were expanding the offer, including cleaning products and perfumery, until today, where they can still be found both in neighborhoods and in cities, commercial premises such as Drugstores.

Requirements to open a drugstore in Colombia

Among the necessary requirements to open a drugstore, we find that the documentation must have:

  1. . A written request to the authorized health agency according to geographic location, for example Departmental Health Institute.
  2. Document that certifies the minimum distance of 75 meters between pharmaceutical service establishments, which is issued by the Planning Secretariat or similar.
  3. The Certification of land use for the pharmaceutical establishment, issued by the Planning Secretariat or similar.
  4. The plan of the premises, with the internal distribution. With a minimum area of ​​20 meters.
  5. The Certificate of Certification from the Chamber of Commerce.
  6. The respective Inscription in Industry and Commerce.
  7. The documents of the person who will act as Technical Director, with a labor contract for a minimum of 8 hours a day. Attach a copy of the credential as a drug dealer and / or pharmacy manager.

It is important to highlight that the pharmaceutical establishment must comply with the provisions of Decree 2200 of 2005 and Resolution 1403 of 2007.

In case of offering the Inyectology service, it must also meet the requirements established in Decree 2330 of 2006 and other regulatory standards.

Steps to follow

Once the required documentation and the conditions of Decree 2200/2005 have been gathered, the steps are:

  1. Deliver the documentation to the respective health agency, according to the form and means available.
  2. The documentation presented will be reviewed and evaluated by the authorized body.
  3. Wait for the visit of the Secretariat staff, to physically make the evaluation of the establishment.
  4. Receive the Operational Certification document.

Rules for opening a drugstore

The operations of a Drugstore are subscribed to Decree 2205 of 2005, which regulates the pharmaceutical service in Colombia.

In this decree two types of pharmaceutical services are proposed: dependent and independent.

The dependent is provided through healthcare institutions such as hospitals, clinics, health centers, etc.

The independent is provided through establishments or pharmaceutical stores. In turn, it is divided into wholesale and retail.

In its Article 11, it is specified that the wholesale pharmaceutical establishments are the Pharmaceutical Laboratories, the Pharmaceutical Specialty Agencies and the Drug Deposits.

While Retail pharmaceutical establishments comprise Pharmacies / Drugstores and Drugstores.

Indicating that the drugstores, will operate under the direction of the professional chemist-pharmacist or a technologist in the regency of Pharmacy. Included a drugstore director or a licensed pharmacist and as well as a drug or medicine dealer.

The drug or medicine dispenser is the most frequent figure in drugstores and is protected under Law 17 of 1974.

It is established that the operations or processes of the establishment are the reception, storage and dispensing or sale of medicines.

Decree 2205 also makes reference to the objective of the pharmaceutical service, in its Article 6 specifies that they are responsible for promoting and motivating healthy lifestyles.

As well as the prevention of risk factors, generated by the inappropriate use of medicines and medical elements, so they must motivate the correct use.

Among other objectives, it indicates that it must supply medicines and medical devices, informing users or patients about their correct use.

And finally, they must offer pharmaceutical care to patients, in all those interventions related to medicines and medical devices that are essential for the purpose for which they were created to be successfully fulfilled.

Other basic provisions are found in the article 8, on the requirements of the Pharmaceutical Service, which At a minimum, they must comply with a physical or local infrastructure, according to the degree of complexity, the number of processes or activities they carry out and the very important of the personnel who work there.

In addition to guaranteeing the existence of equipment, instruments, materials and bibliography, required to be able to comply with the processes in each of the units that comprise it.

In relation to the Human talent, this must be suitable, with adequate preparation to carry out the specific activities of each process.

In addition to other provisions related to drugstores such as retail establishments of pharmaceutical services.

Locative aspects to open a pharmacy

Regarding the conditions of the premises or physical infrastructure required to open a pharmacy, it should be noted that according to the Municipal Planning office or some similar authority according to the municipality, There must be a minimum distance of seventy-five (75) meters, without exception, between the closest retail pharmaceutical establishment and the one we intend to open.

Specifically for the premises must have a minimum area of ​​twenty square meters 20m2Taking into account that to offer injection services, you must have an adequate space apart from other areas, in addition to other requirements for this specific service.

However, depending on the volume of medicines to be handled, the activities to be carried out, the services offered and the number of employees, the area must be in accordance with these factors, that is, greater than the minimum required.

further the premises must have good lighting, adequate ventilation in each area, healthy maintenance of floors, walls and ceilings. Without forgetting the electrical installations, hygiene and sanitary areas, ensuring that quality preservation of medicines and medical devices is generated.

It’s important pointing that Aspects such as ease of access to the establishment are considered, signaling of restricted circulation in areas for storage and other processes.

As well as the independence in relation to other different areas of the commercial establishment, such as a room, an office or a medicine warehouse.

recommendations

The opening of a pharmacy, carries an important moral weight, since somehow health is sold through it.

But in the same way it is a business and therefore It must comply with the regulations in force for the creation of a commercial establishment, in addition to the sanitary licenses for its operation.

We must remember that non-compliance could lead to the application of sanctions and / or fines, which may result, in the worst case, in the non-opening or temporary or permanent closure of the premises.

Must be look for serious and trustworthy suppliers that provide drugs suitable for sale to the public, as well as knocking on the door to wholesalers who can offer more profitable prices and terms. What helps you to offer products at solidarity prices and obtain more customers and higher returns.

In the first stage of any business, the time of dedication is at 1000%, get the point, neighborhood trust, good suppliers, takes your time.

Make a lucrative salary plan for employees, do not skimp on their income, remember that they are the face of your business. Happy and grateful employee, satisfied public, and successful business.

Products that can be sold in a pharmacy

In relation to pharmaceuticals and medical devices to offer in the pharmacy, the law requires that they be acquired from duly authorized suppliers for sale to the public.

You can request the certification issued by the Office of Drug Control to ensure the correct status of said provider.

For the rest of the products sold on the premises, It must comply with the established health regulations, without the application of any excuse for its non-compliance.

Hoping to have served you!

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