Requirements to open a Pharmacy in Colombia

9 minutos de lectura

If you are thinking of opening a pharmacy, you have come to the right website. Here we will inform you about the Requirements to open a Pharmacy or also called a drugstore in Colombia.

If this topic is of interest to you, keep reading and find out more about each of the steps to follow to open your business.

In such a way that you are clear about the steps you must follow, to achieve that business you want so much.

What are the requirements to open a pharmacy in Colombia?

Within the Requirements to open a Pharmacy in Colombia. Compliance with the rules established by the District Health Secretariat and the Chamber of Commerce must be taken into account.

The main point should be to study the distance between one pharmacy and another (75 meters). If this is not complied with, the relevant bodies will not approve the authorization to operate.

It is important to have the necessary studies of pharmacy and injection, accredited by an institute approved by the corresponding entities.

Preferably have a minimum capital of 15 million pesos, to start supplying the pharmacy. Obviously you will start with the simplest (pain relievers, personal hygiene products, candy, hygiene items for children, etc.).

It is convenient conduct a market study. The requirements of the site where the trade is to be opened must also be known. Since it is not a question of thinking that because people get sick, it is necessary to set up a pharmacy.

Complying with the requirements of a sanitary nature is also essential. For example, you must have a Technical Director who endorses the business. This must be a Licensed Pharmacist or a Pharmaceutical Chemist. Its validity must be accredited to dispense drugs or have a Director’s course in 1975.

Important

The main objective of the pharmacist is to provide social health care. This facilitates help, without the intention of replacing the doctor for any reason.

Documents needed as Requirements to open a Pharmacy in Colombia

The necessary documents such as Requirements to open a Pharmacy in Colombia, they are named below:

  • Submit a request in writing.
  • Attach a certificate showing the required minimum distance of 75 meters. Which is requested in the Planning Secretariat.
  • The certificate of use of the soil for the pharmaceutical premises. It is also requested at the Planning Secretariat.
  • Design of the establishment the minimum area required is 20 meters. Point out the internal division.
  • The certification granted by the Chamber of Commerce.
  • Registration in Industry and Commerce.
  • The documents of the Technical Director (the Regent of Pharmacy, the professional card. Also a contract of at least 8 hours).
  • The receipt of the documents requested by the entity.
  • Verification and evaluation of the documents consigned.
  • Assistance of the employees of the Secretariat to assess the commercial premises.
  • The certificate of operation.

Note

The commercial premises must comply with the provisions of the Decree 2200 of the year 2005 and Resolution 1403 of 2007. Therefore, if you want to provide an injection service, you have to comply with the requirements found in Decree 2330 of 2006.

Regulations that a Pharmacy in Colombia must comply with

There are a series of laws with regulations that a pharmacy in Colombia must comply with. We will name them below:

Basic rules

Some of the basic laws that the drugstore must comply with are the following:

  • Law 23 of 1962, which regulates the powers of the Pharmaceutical Chemist.
  • Law 47 of the year 1967, where the Intermediate Profession as Regent of Pharmacy is created.
  • Law 8 of 1971, in this Law 47 of 1967 is rectified.
  • Law 17 of 1974, here Law 8 of 1971 is rectified.
  • Law 212 of 1995, which regulates the Profession as a Pharmaceutical Chemist.
  • Decree 1959 of 1964, which regulates Law 23 of 1962, about the functions of the Profession as a Pharmaceutical chemist.
  • Decree 2200 of 2005, here regulates the pharmaceutical service and other standards. Regulates operations and procedures of a pharmaceutical nature.
  • Decree 2330 of 2006, which rectifies Decree 2200 of 2005 and regulates the injection service.

Medicines

  • Law 9 of 1979 of the National Health Code.
  • Decree 2092 of the year 1986, manufacture, wrapping or container, deposit. The transfer and sale of medicines, cosmetics and the like.
  • Decree 677 of 1995, which stipulates the procedures of the Regime of Registries and Licenses. Quality control and the Medicines Health Surveillance Regime.
  • Cosmetics, Pharmaceutical preparations based on Elements of Natural origin, etc.
  • Resolution 114 of 2004, which regulates promotional or advertising data for over-the-counter medicines.
  • Resolution 0234 of the year 2005 of the District Secretary of Health, record and write down what the numeral 1 of the agreement 145 of 2005 says. Medicines for sale with medical prescription.

Homeopathic Products

  • Decree 3554 of 2004, the regulation of sanitary registration, inspection and sanitary verification of homeopathic medicines for human consumption.
  • Decree 1737 of 2005, regulates the preparation, placement, sale, marking, identification and packaging of magisterial and pharmaceutical homeopathic medicines.
  • Decree 1861 of 2006, where Decree 3554 of 2004 is modified and included, and other variables are determined.

Phytotherapeutic Medicines

  • Decree 2092 of 1986, manufacture, wrapping or container, deposit, transfer and sale of medicines, cosmetics and the like.
  • Decree 337 of 1998, regulations on natural resources used in pharmaceutical preparations.
  • Decree 2266 of 2004, here regulates the regimes of sanitary registries, control, sanitary inspection and propaganda of phytotherapeutic articles.
  • Decree 3553 of 2004, where Decree 2266 of 2004 is rectified.
  • Resolution 4320 of the year 2004, which regulates the propaganda of medicines and phytotherapeutic elements for sale without a medical prescription or for free sale.

The cosmetics

  • Decree 219 of 1998, regulates the regimes of sanitary records, inspection, sanitary verification and advertising of articles
  • Decision 516, to agree on the legislation on Cosmetic Products.
  • Resolution 2003024596 of 2003, to unify the method that encrypts cosmetic products according to Decision 516.

The White Drug

Resolution 243630 of 1999, where the concepts related to white drugs are admitted.

Dietary Supplements

Decree 3249 of 2006, which regulates the production, wrapping or container, sale, identification, marking. Health registration, quality control, among other dietary supplements, and Decree 3636 of 2005 is abolished.

Functions of a Drug Store in Colombia

In a Drug Store in Colombia there are different functions, which will depend on the position of each employee. These will be specified below:

Manager

Regarding its general functions, there are: Manage the business, make the final decisions, monitor that all the established standards are met. Fulfill its function as legal representative at the time it is needed.

Among its specific functions are: The organization of physical elements, their replacement and conservation. Organization of all personnel, employment contracts, payment of salaries. Also of dismissals, stipulation of working hours and working terms in general.

Inspection of the rules of purchases, deposit and exit of products for sale. Be the image of the business in all obligations of a commercial or social nature.

Stipulate serious criteria for the fulfillment of financial obligations. Inspect the prices and expenses that are produced by the management of the business and make the respective decisions.

Organize and control cash and the investments made with it. Encourage the progress and consolidation of the business.

The Pharmacy Technologist

Its general functions are: Direct the processes within the business, receive and dispense pharmaceutical items. Monitor so that the norms established in the business are fulfilled. Fulfill its function as legal representative at the time it is needed.

The specific functions of the Pharmacy Technologist are the following: The organization of physical elements, their replacement and conservation. Inspection of the rules of entry, deposit and sale of products for sale.

Be the image of the business in all commercial or social obligations. Encourage the progress and consolidation of the business. He is responsible for managing the administration and dispensing of medicines.

Pharmacy and Sales Assistant

His main function is: To be the sales assistant of the business, and to receive the pharmaceutical products, to ensure that the regulations are met. Support in the conservation of each one of the medicines of the business.

Help in the maintenance and permanence of the business, take care of dispatch items to sell. Be the image of the business in all commercial or social obligations.

Stimulate the progress and consolidation of the business. Protect the physical elements of the business and receive the medicines.

The Pharmacy Messenger

Its general function is: To deliver medicines at home, also to make shipments and delivery of documents. And it runs various services such as keeping the business clean.

Make the dispatch of the items for the home sale. Be the image of the business in all commercial or social obligations.

Encourage the progress and consolidation of the business. Protect physical items of the business and receive the medicines. Respond for the cleanliness of the business.

All pharmacy personnel have the right and duty once a year to attend seminars. They are organized by state laboratories and agencies, with the aim of keeping them updated on processes and decrees.

How should the site of a Pharmacy in Colombia be?

The place that a pharmacy occupies in Colombia must be a space destined for the sale of psychotropic drugs. In addition to alkaloids, barbiturates, narcotic drugs, corticosteroids and oxytocics.

As well as the sale of chemical substances, official drugs. Special pharmacy products, generic drugs, hygiene, food and diet items.

In the same way, in charge of the sale of products or over-the-counter pharmaceutical preparations. Also rodenticides, rodenticides. Also similar products, such as cosmetics, articles for healing.

On the other hand, the sale of pharmaceutical chemistry support instruments, and an area for the creation of master formulas.

What is a Drug Store in Colombia?

A drugstore in Colombia is one that takes care of trade drugs which are the basic material of biological origin. It is used for the manufacture of medicines.

The chemical structure of drugs is responsible for producing a pharmacological substance, which will be necessary in treatments. Thus achieving recovery for any alteration or condition.

In order to provide customers with comfort. They also offer a wide variety of cosmetic items (soap, oral care, makeup, lotions, etc.).

Through this article, you already have the necessary information about the Requirements to open a Pharmacy in Colombia.

Therefore, you must bear in mind all the legal regulations with which you have to comply. In this way, your business can operate correctly and efficiently.

In this link you can find more information of interest. We hope we have helped you.

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