Requirements to Open a Pharmacy: Step by Step, Regulation and MORE

8 minutos de lectura

The Requirements to Open a Pharmacy They are really important because they will allow you not only to know what you need in terms of documentation, but also in terms of starting up your pharmaceutical business.

We all know some pharmacies, We know that they generally don’t just sell medicines, they can also sell food products, beauty and hygiene products, and much more. However, the word pharmacy refers to a place where medicines and other health products are created, kept, and sold.

In this article we will explain the step-by-step, along with the requirements, that you need to follow to open your own pharmaceutical business. In addition, we will point out the costs, permits and some recommendations that you have to take into account. Do not go!

What are the Requirements to Open a Pharmacy in Chile?

Let’s talk about the Requirements to Open a Pharmacy First of all, so we can move on to exactly what you need to do to open this business. Keep in mind that all of these are very important, as they will determine the approval of your application as responsible for selling drugs.

Let’s see:

Requirements to Install a Pharmacy

  • Copy of the social contract, legalized before a notary. This must be registered in the Commercial Registry and with its respective publication in the Official Gazette.
  • Municipal number act of the address of the premises.
  • Fee payment receipt respective (4150001).
  • Copy of the deed or lease, either the owner or the tenant of the property. In the latter case, the name of the owner or legal representative (who signs it) must be reflected, so that the possession of the premises is justified or supported. These documents must be authorized.
  • Site-scale design where the pharmacy will be installed, where the function of the dependencies can be seen, such as the offices, bathrooms, the pharmaceutical chemist’s office, etc., and the distribution, doors, and symbols of their implementation (shelves, fire extinguishers, furniture, etc.)
  • Application for Sanitary Authorization.
  • Declaration of the person who will be in charge of the Technical Directorate of the Establishment. This must be a professional and the statement must be signed, reflecting the address, profession, RUN, work schedule, specifically the day to be fulfilled. In addition, the record must be attached to the Superintendency of Health or a photocopy of the title (legalized).
  • Letter signed by the legal representative, where an introduction is made to the Technical Director, as well as to all complementary professionals. In addition, the record must be attached to the Superintendency of Health or a photocopy of the title (legalized).
  • Attend the respective Legal Framework to the opening of a pharmacy.

Requirements for the Operation of the Pharmacy

  • Sanitary authorization for all collaboration personnel, which must be processed by the pertinent Regional Ministerial Secretary. This will be previously verified by the Technical Director.
  • There must be in inventories bioequivalent products, as well as all those indicated in Title IX of Supreme Decree 466/84 “Pharmacy Request”. Supreme Decree No. 22/2009 that establishes modifications to D .S. 466/84.
  • Each one, without exception, of the products to be sold, must indicate their sale price.
  • Book stamp request from official records.
  • Lockable shelf where only poisons and psychotropics are found.
  • Signs in the establishment and other requirements according to the Institute of Public Health contents here.

All the Requirements to Open a Pharmacy they are just as important, so it’s good to keep them in mind. We encourage you to enter the website of the Institute of Public Health, so that you can find out more regulations.

Step by Step

Now let’s talk about procedure you must follow to open a pharmacy in Chile, Well, it is very important that you have an idea of ​​what you have to do. Let’s see:

  • The first step is investigate about it, what you already did if you got to this point.
  • Second, you have to complete the FARMA form F-01, which you can access by clicking here or by going to the website of the Institute of Public Health. This is done to request approval from the pharmacy facility. This must go in conjunction with the documents we mentioned above.
  • In third place, fill out the FARMA-02 form, which you can access by clicking here or by going to the website of the Institute of Public Health. This is done to request the approval of the pharmacy operation. It must be accompanied with the documents and requirements that we mentioned above, and the number and date of the approval of the installation of the premises, declaration of own capital and the receipt of the payment of the corresponding fee (4160002).
  • If you already have authorization to purchase pharmaceutical products, you just have to complete the form FARMA-03, for the installation and operation of the pharmacy.
  • Later the application and background check. In this step, additional documents can be requested, if necessary.
  • If the above step is completed successfully, the visit will be scheduled. The Technical Director and a representative of the owner company must be present for this. It can be done in two stages: to see the facilities and / or to see the operation and complete this step of verification of the place. Everything must coincide with what is expressed in the form.
  • Finally, you will be able to start the activities of the pharmacy when the Authorization Resolution is issued, which can be notified via email or telephone, this, of course, in the event that the Request is accepted.

The approval or disapproval of the Request could last up to 15 business days, counting from all receipt of the necessary documentation.

How much money is needed to open a pharmacy in Chile?

You will be wondering how much is the investment necessary to open a pharmacy in ChileWell, the truth is that the most important thing to keep in mind is that this is a stable business, since so is the demand for drugs.

The cost of opening a pharmacyThus, it can be around $ 200,000- $ 500,000, if you like, but that will depend on your situation. If you have credits, own funds, a guarantee, an asset to mortgage so that you can make this investment. The important thing is that the business is profitable, if you are going to request a loan from the bank, and take into account its location and little else.

Regulations for Pharmacies in Chile

Opening a pharmacy requires attending a respective legal framework, and as we saw that following this regulation is one of the Requirements to Open a Pharmacy.

  • Decree Force of Law No. 725 of 1967, Health Code.
  • Law No. 20,724 of 2014 of the Ministry of Health.
  • Decree No. 466 of 1984, No. 404 of 1983, No. 405 of 1983, No. 79 of 2010, No. 3 of 2010 of the MINSAL. This includes the regulation of pharmacies, drugstores, pharmaceutical warehouses, first-aid kits and warehouses; of Narcotics; of psychotropics; the one applicable to the Preparation of Pharmaceutical Preparations in Pharmacy Recipes; and that of the National System for the Control of Pharmaceutical Products, respectively.
  • Guide for the Authorization and Inspection of Pharmaceutical establishments for the
    Health services.
  • Decree Force of Law No. 1 of 1989, which has as title: Determines Matters that Require Express Sanitary Authorization.
  • Supreme Decree No. 75 of 2001, of the MINVU, General Ordinance of Urbanization and
  • Law 20,000, that speaks of illicit trafficking.
  • Supreme Decree No. 148 of 2003, No. 239 of 2002, No. 825 of 1998, of the MINSAL. Here the Health Regulations on the management of Hazardous Waste, the Control of Cosmetics and the control of Products and Items for Medical Use, respectively, will be reflected.
  • Cold Chain Technical Standards, of the Ministry of Health.
  • Supreme Decree No. 594 of 1999, which contains the Regulation on the sanitary characteristics of the work area, as well as environmental conditions.
  • Law 20.660 and Law 20,422. The first talks about smoke-free places and the second about Equal Opportunity and Inclusion of People with Disabilities.

Recommendations when Opening a Pharmacy

Finally, to finish this article, we would like to give you some recommendations when opening a pharmacy.

Let’s see what they are:

  • Includes non-pharmaceutical products to increase your income or at least ensure that you keep it constant. All the pharmacies that we know sell hygiene products, cosmetics and more.
  • Train your staff so that they can meet the wishes of customers in the best possible way.
  • Get to know your customers, position the products you want to sell to the customer’s hand and always have the best sellers or recommended ones in stock.
  • Offers point of sale, mobile payment or transfer, because the flexibility of payment will make you a better option for customers.
  • Use social media, make yourself known in the community.
  • Consider the products that customers ask about: Is there soap of a certain brand? Certain medication? If this requirement is repeated, you should definitely include it in the list of products for sale.
  • If you can, places the pharmacy where people can easily see and access it, as is the case of the main avenue. And if there is a space to park, the better.

Finally, don’t be afraid to start a new business. Always go with the best disposition to offer quality service and products, especially now that we know the Requirements to Open a Pharmacy.


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