Pharmacies have always had the right to preferential taxation. Organizations opening pharmacies became payers of a single tax on imputed activities. Individual entrepreneurs could choose between UTII and PSN - the patent taxation system. From January 1, 2021, everything will change. The Government of the Russian Federation has made changes to both the Tax Code and the legislation regulating the circulation of medicines. Pharmacies will have to refuse UTII and PSN.
Starting from the new year, a new task will appear - which tax regime to choose for a pharmacy. If you are in doubt and cannot calculate which taxation system is more suitable for your pharmacy establishment and whether you have the right to apply preferential programs (STS), contact a tax lawyer. A tax specialist will help you decide on a new regime and close the old one - UTII or PSN.
Cancellation of UTII and PNS
Reforming the pharmacy tax system has been planned for a long time. Now most pharmacies apply UTII - a single tax on imputed income, or imputation. If a pharmacy was opened by an individual entrepreneur, then he had the opportunity to choose between UTII and PSN - he declared imputation or received a patent for the retail sale of medicines.
UTII is becoming an irrelevant tax system, and everything is heading towards the fact that the tax authorities will abolish it. The first serious step will be taken on January 1, 2021. This is what will happen: many goods will begin to be labeled, and they will not be able to be sold in retail trade (Article 346.27 of the Tax Code of the Russian Federation). This also applies to medicines. Now all drugs and medicines are subject to mandatory labeling (Bill No. 834261-7). This is what will affect the taxation of pharmacies.
How it works? Products that contain any medicines are marked. All manufacturers and distributors of medicines (pharmacies or intermediaries) are registered in the Honest Sign system. Pharmacies purchase medications through this system and record the sale of drugs in it.
According to the new tax legislation, the sale of medicines with labeling and mandatory identifiers is not retail trade (clause 58 of Article 2 of 325-FZ of September 29, 2019). If a pharmacy ceases to engage in retail trade, then it does not have the right to use taxation under UTII or PSN. It turns out that the moment a pharmacy sells at least one medicine with a label, it loses the right to apply imputation or a patent taxation system.
It is logical that from January 1, 2021, pharmacies will not be able to use their old tax regimes (UTII, PSN). After the termination of commercial activities subject to a single imputed tax, pharmacy owners are required to notify the Federal Tax Service within five working days and switch to a new tax regime. But the beginning of January is always holidays, which means non-working days. Tax officials are giving a deferment - pharmacies will be able to switch to the new tax system until January 15, 2020.
There is one caveat - pharmacies have the right to sell without labeling those goods that were produced in 2021 and have an appropriate remaining shelf life (with the exception of drugs labeled on 10/01/2019). But, again, this does not in any way affect the change in the taxation system, because labeled drugs will also be sold along with unlabeled drugs.
To get away from the old tax regime, the owner of the pharmacy needs to submit an application to the territorial tax office. Organizations submit the UTII-3 form, and individual entrepreneurs submit the UTII-4 form. Do this no later than January 15, 2020!
How to open a pharmacy? Types of pharmacies and choice of OKVED
According to Order of the Ministry of Health and Social Development of the Russian Federation dated July 27, 2010 N 553n “On approval of types of pharmacy organizations,” pharmacy organizations are divided into the following types: 1. Pharmacy of finished dosage forms; 2. Industrial pharmacy; 3. Manufacturing pharmacy with the right to manufacture aseptic medications; 4. Pharmacy. 5. Pharmacy kiosk.
To open a pharmacy that will produce medicines (types 2 and 3 of pharmacy organizations), you will need to select OKVED codes for the “Production of Medicines” group (24.42 Production of Pharmaceuticals and Materials). If production is not planned, then it will be possible to select only OKVED codes suitable for trade:
- 52.31 Retail trade in pharmaceutical products
- 52.32 Retail trade in medical products and orthopedic products
- 52.33 Retail trade in perfumery and cosmetic products
Note! Before carrying out activities to trade perfumes and cosmetics, you will need to notify Rospotrebnadzor.
When choosing the type of pharmacy organization, you should take into account that in a pharmacy of finished dosage forms, unlike a kiosk, it will be possible to sell prescription drugs. In addition, it will be possible to open pharmacy points on the basis of the pharmacy.
Documents for opening a pharmacy
To register a business you will need:
For individual entrepreneurs:
- Application on form P21001
- Payment of state duty in the amount of 800 rubles.
For LLC:
- Charter
- Decision of the sole founder or minutes of the general meeting of founders
- Payment of state duty - 4000 rubles.
Other documents (as required):
- letter of guarantee from the owner of the premises at the location of the LLC or other title documents for the right to use the premises
- agreement on the establishment of an LLC (if there are several founders)
To operate a pharmacy you will need:
- Conclusion of Rospotrebnadzor on compliance of pharmacy premises with established requirements
- Permission from Rospozhnadzor
- License for pharmaceutical activities
- Notification of Rospotrebnadzor when carrying out activities under code 52.33
As you can see, opening a pharmacy from scratch is a rather complicated and lengthy process. It may take more than one month to obtain and process all necessary permits.
Transition to other tax regimes
By default, it is believed that pharmacies that have lost the right to use UTII automatically switch to the general taxation system - OSNO. But this is not entirely true - owners have the right to choose the tax regime.
So, from January 1, 2020, pharmacies will not be able to use UTII and PSN. Two tax regimes will become available for organizations and individual entrepreneurs:
- General taxation system (OSNO) . The general regime carries the largest tax burden for pharmacies - with mandatory payment of VAT, personal income tax, income taxes, property taxes and transport fees (if there are vehicles).
- Simplified taxation system (STS, simplified) . This is a preferential tax regime that implies two options for paying tax. The owner of a pharmacy can choose an income scheme and pay a single tax of 6%, or the “income minus expenses” method and transfer 15% to the budget. Let’s say right away that the second option is more profitable for pharmacies, since their expenses are quite large, which can significantly reduce the final tax amount.
To switch to OSNO, no additional applications or documents are required. After submitting UTII forms 3 and 4, tax authorities will automatically transfer the pharmacy to the general taxation system.
With the simplified tax system everything is a little more complicated. This is a preferential tax regime, so not all organizations or individual entrepreneurs can apply it. A pharmacy can issue a simplified tax system if:
- the residual value of fixed assets is not higher than 150 million rubles;
- the average number of employees is no more than 100 people;
- total revenue for the three previous quarters (nine months) is 112.5 million rubles, for the annual period - 150 million rubles.
These are quite high figures, so most pharmacies have the right to apply for a simplified form. Moreover, tax authorities allow minor violations of regulations. If during the reporting period the number of employees increases to 130 people, and annual revenue increases to 200 million rubles, then the Federal Tax Service, as a fine, will increase the single tax rate under the simplified tax system to 8% for the income method and 20% for the expense method.
However, to switch to the simplified tax system, business owners will have to hurry. You can apply for a simplified tax regime only if you refuse UTII in 2021 and immediately submit a notification (form No. 26.2-1) about the appointment of the simplified tax system. The deadline for informing tax authorities is December 31, 2019. If you don’t make it in time, then from 01/01/2020 you will work for OSNO.
Sources:
On amendments to the legislation on the circulation of medicines
On amendments to the Tax Code of the Russian Federation
About retail
Container, packaging and completeness of medicines
No longer in force on 12/31/2020: Order of the Ministry of Health of the Russian Federation dated December 21, 2021 N 979n “On approval of requirements for container volume, packaging and completeness of medicinal products for medical use.”
Entered into force: Order of the Ministry of Health of Russia dated July 31, 2020 N 779n “On approval of requirements for container volume, packaging and completeness of medicinal products for medical use.”
Comment: The production of drugs intended for internal use, as well as their sale and transfer, is carried out by drug manufacturers in containers containing the volume of the drug:
- no more than 25 ml with a volume fraction of alcohol over 50% and a course dose of drugs no more than 75 ml inclusive; - no more than 50 ml with a volume fraction of alcohol from 30% to 50% and a course dose of drugs not more than 100 ml inclusive; - no more than 100 ml with a volume fraction of alcohol up to 30% and a course dose of drugs not exceeding 200 ml inclusive.
The concentration of alcohol included in the medicinal product is indicated on the primary and secondary (if any) packaging. Manufacturers, when selling and transferring drugs, complete them in accordance with the instructions for medical use of the drug.
No longer in force on 12/31/2020: Order of the Ministry of Health of the Russian Federation dated February 8, 2021 N 47n “On approval of the list of medicinal products for medical use, for which requirements for container volume, packaging and completeness are established.”
Entered into force: Order of the Ministry of Health of Russia dated July 31, 2020 N 778n “On approval of the list of medicinal products for medical use, for which requirements for container volume, packaging and completeness are established.”
Comment: A list of alcohol-containing tinctures, drops, extracts and elixirs has been approved, in respect of which the requirements of Order 779n are established.
Drug quality
Expired 12/31/2020:
- Order of the Ministry of Health of the Russian Federation dated July 16, 1997 N 214 “On quality control of medicines manufactured in pharmacy organizations (pharmacies).”
- Order of the Ministry of Health of the Russian Federation of October 16, 1997 N 305 “On the norms of deviations permissible in the manufacture of medicines and packaging of industrial products in pharmacies.”
- Order of the Ministry of Health of the Russian Federation of October 21, 1997 N 308 “On approval of the Instructions for the manufacture of liquid dosage forms in pharmacies.”
4.Order of the Ministry of Health of the Russian Federation dated July 20, 2001 N 284 “On approval of norms for the natural loss of medicines and medical products in pharmacy organizations, regardless of the legal form and form of ownership.”
Continues to be in force: In 2021, Order of the Ministry of Health of Russia dated October 26, 2015 N 751n, already familiar to all pharmacy workers, continues to be in effect “On approval of the rules for the manufacture and dispensing of medicinal products for medical use by pharmacy organizations and individual entrepreneurs holding a license for pharmaceutical activities”
Comment: When Order 751n was published, it did not cancel orders 214, 305, 308 and 284, which led to duplication and discrepancies. This defect has now been eliminated.
Order 751n contains not only the rules for the manufacture of different types of dosage forms and types of control, but also all the necessary information used in the manufacture of medicines in industrial pharmacies.
Sanitary regime in pharmacies
Expired on December 31, 2020: Order of the Ministry of Health of the Russian Federation dated October 21, 1997 N 309 “On approval of the Instructions on the sanitary regime of pharmacy organizations (pharmacies).”
Entered into force on 01/01/2021: Resolution of the Chief State Sanitary Doctor of the Russian Federation dated December 24, 2020 No. 44 “On approval of sanitary rules SP 2.1.3678 - 20 “Sanitary and epidemiological requirements for the operation of premises, buildings, structures, equipment and transport, and also the conditions of activity of economic entities engaged in the sale of goods, performance of work or provision of services.”
Comment: The fifth section of this resolution is devoted to pharmacy organizations and is called “Sanitary and epidemiological requirements for the provision of services by pharmacy organizations”
