Under the term of applicability medicinal products rozumієtsya hour, by the stretch of which the products are given in accordance with all the necessary normative documentation. Postal date according to the term of applicability is the date of issue. With this recommendation, remember to save money, but do not only pay for savings, but also for transportation and sale. Call for products to be sold with such a rozrahunkom, so that the excess term of applicability, allowing the purchase of more vicarious items before the end of the term of applicability. At the link with the implementation of medicinal products, wines are richly nourished, zokrema. juridical character, connected with the policy of the post-employees and about those, which period should be taken into account by a sufficient amount of recognition of the LZ for recognition.
The greater number of post-employees should confirm at the agreement the extra term of affiliation of the medicinal product, which is clear to them. Zvhichay tsya intera vіyuєtsya vіd 80 to 50%. But how can the term of appurtenance at the borders, after the passage of the majestic Lantsyuzhka of firms-intermediaries, how can they be in their own regions of the country, to ensure the sameness of the Kіntsevskomu spozhivachev? When passing the goods, it is possible to turn back, the term is the passage of the goods from your own. A single statement about the term of applicability is used in clause 5.9. OST 91500.05.005-2002, paragraph 3 of the return to the goods: “what if the terms of attachment are accepted”. Lack of nutrition: what term of appurtenance is acceptable? How should pharmacy organizations behave when laying down contracts?
Zgidno Civil Code The RF term of appurtenance is recognized as "strings, if such a product is considered irrelevant in the name of recognition". Legislation determines the transfer of such goods, where to enter, zokrema, LP. In its own right, the need for a strict legal regulation of the obigu of medical benefits is cited by their high social significance as objects of civil obigu. It’s very important, so that the end result of the medical care was not only effective, but also safe for health.
Necessary and sufficient
One of the important parameters, which is added to the quality of pharmaceutical products, is the term of applicability. However, the problem of Russian legislation is left without due respect. So, the single stipulation that the term of admissibility to the drug should be accepted is that the seller must “hand over the buyers with such a rozrachunk, so that they will win a moment of recognition for recognition before the end of the term of admissibility” (Article 472 of the Central Committee of Ukraine). Until 2010 The Rules for the wholesale trade in medicinal products had one more statement on the term of applicability: in clause 5.9, the concept of “acceptable term of applicability” was fixed, for specific criteria, as if it were allowed to designate, which term is considered acceptable, the law is not passed. Moreover, the Rules of Wholesale Trade, approved by the order of the Ministry of Health and Health until today, have no such understanding in principle. The procedure for the admission of the medicinal product has to bypass the Danish aspect of the characteristics of the preparations that are admitted by the party.
In this way, at the current moment, the smut is considered to be what period should be considered sufficient for recognition for recognition, especially for the LP. Most of them, for the sake of food products, for example, can’t be beaten for a short period of time, donated for the singing course of the liquor, at the borders of such a patient is guilty of accepting zasib. How can you consider the “victory for recognition” situation, if the patient can take only half of the tablets before the end of the term of admissibility?
At this court, vihodyachi z Art. 472 of the DK RF, may be a bіk of a post-employee, viznayuchi navіt netrivaliy termіn sufficient realіzacії goods, and the provision of this termіn - insufficient pіdstavoy nevikonannya by the buyer of his obov'yazkіv z payment for the goods. To rob the pharmacy organizations with the most expansive lanka in the lances of the animals.
To help solve this problem, standards, adopted behind the cordon, can be used to introduce them into Russian practice. stay rocky. Before them, one can add the standards of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP). GMP standards are being extended to pharmaceuticals. Dotrimanny GMP standards allow them to say with greater confidence that the statements on the packaging of the drug the term of applicability is valid. Even more important is the GDP standard, which regulates the activities of wholesalers. So, the term of applicability can be called a provision on the turnover of medicines in warehouses, as well as fixing the appearance of drugs in the Russian legal system of computerization with the term of applicability. Werewolf allows you to minimize the use of the drug in the wholesale warehouse, and therefore, save an hour, which drug can be taken without interruption at the end of the line. In addition, the procedure for turning is regulated, which allows you to change the shortest term. Nareshti, the GPP standards allow achieving such results on the level of pharmacy organizations. Dotrimannya tsikh norms usima by the participants of obigu LP guaranty the quality of likіv, regardless of the term of appurtenance, scho overflowing.
Krym zastosuvannya zaznacheniyakh standards in necessary and thoroughly in the light of Russian legislation. So, it is necessary to concretize the concept of “acceptable term” for different categories of goods. Zocrema, for preparations, in our opinion, such a term can be at least not less, lower period, for which the rate of coverage of these drugs, appointments in the instructions. Qiu Umova can be included in the contract with a specific postal worker.
Let's get home
If you are talking about the current situation, then the only order of pharmacy organizations is freedom of contract and building to dictate mind, guide it. So, in order to reduce the risks, it is necessary to include a mind before the contract, in order to help balance the interests of the parties. Firstly, install at the contract the postal manager for the supply of goods beyond the scope of the established term of attachment (for example, less than 50%), to the vіdmovi vіd priymannya goods. In another way, you can include before the contract the return to the postal manager of the goods, which was not sold before the completion of the term of attachment. In case of any doubt, zgіdno z zgіdno z in zіmu vpadku, vrakhovuyuchi sumlіnne vykonannya goitre by the seller, the return is made out at the sight of a new supply contract, where the parties change their roles. At your own expense, the purchase of a purchase for payment for the goods under the first contract can be on the pіdstavі st.
In fact, the technical order is a document that avenges the deputy's deputy to the object of purchase. At the new one, wash that order of її carrying out, and also wash the supply of goods, vikonanny robіt, or nadanny of the services of that її priymannya. Zamovnik rozroblyaє okreme tehnіchne zavdannya pіd kozhnu specific purchase.
Can you get away from the technical manager?
Theoretically, yes. It is not necessary to supervise the law on state purchases, as if the project had a contract, related to that purchasing documentation presented report information about the object of purchase. But in practice, it’s still better to fold the technical report, so as not to blame the difficult moments when reading the purchasing documentation by the supplier.
What does it take to insure the hour of storage of a technical manager?
It is important to believe that the description of the object of purchase of the deputy may have an objective character. Accordingly, up to paragraph 1 of part 1 of article 33 44-FZ, in the description of the object of purchase, functional, technical and other characteristics, operational characteristics of the object of purchase (for consumption) are indicated. The technical manager is not guilty of transferring more risks for the post-employee and tighter, lower for the deputy.
Warehouse technical manager contract service or a contract manager at the same time as a lawyer, a specialist in a structural subdivision. The headstone of the deputy yogo signed. The manager includes the warehouse of technical specifications to the warehouse of the purchasing documentation, and the participant of the purchase - he will be able to complete the TK when storing his applications.
Would you like to know more? Take a distance online course
Would you like to conduct a participant in the procurement of an examination of a technical department?
The deputy manager of the technical order on the official website at the warehouse of the purchasing documentation. Can a procurement participant carry out an examination of this factory?
So, the participant of the purchaser may have the right to conduct an examination, to that there are no legislators here.
From the moment of placement on the official website, all information about the purchase becomes available to the non-restricted stake of the company. As a participant of the purchase for the formation of his own propositions, it is necessary to analyze the technical order, to reconsider the priming of the installed forces, you can work independently, so turning to an expert organization.
The order and criteria for reconsideration of the technical order are not established by the law on public procurement, so the participant in the procurement can independently or praise the order that the expert organization promotes. And then they gave virishuvati, chi varto to you take a part in this purchase, chi you can deliver the goods (visit the robot to give a service), which is a good technical task. The participant in the purchase may denounce the provisions of the documentation.
The term of appurtenance in vіdsotkah - how is it possible?
Can you install a substitute for a technical manager to a superfluous term for attaching goods to a product?
Positions of controlling and judicial authorities given food disperse. In a number of arbitral tribunals, the judges consider that such a deputy’s deputy is unlawful. The stench is succumbing to those that we can bring to the fringe of competition.
When describing the object of purchase, the zamovnik can indicate in the documentation that the protection is up to the guarantee line (part 4 of article 33 44-FZ). However, it is not possible to include in the description of the object of purchase the goods and information, which would cause the exchange of the number of participants in the purchase. Vinyatok become violent, if there is no other way to accurately describe the object of purchase (clause 1, part 1, article 33 44-FZ).
The Federal Antimonopoly Service of Russia, in clarifying the opinions, makes it clear that it is possible to establish a superfluous term of applicability in cases of illegality (List of 26.08.2014 No. AK / 34487/14).
Ale trapleyayutsya vpadki, if the FAS vvazhaє, scho zamovnik can explain the term of attachment to vіdsotkah. Vymog to the surplus term pridatnostі can be adjusted to the needs of the consumer of the goods. For example, a medicinal preparation can be requested not only for a short period of time, during which time purchases are made, but after completion.
Previously, when looking at similar supercars, during the period of 94-FZ, the FAS of Russia and arbitration judges ruled that this might be lawful (Decision of the FAS of Russia on 10/13/2011 at reference No. K-2255/11, on 10/13/2011 at reference No. K-225 /11, Decree of the Federal Antimonopoly Service of the Central District, dated November 21, 2012, reference No. А08-10203/2011). Or rather, designate the excess term of appurtenance with a period (for example, at the dates, months, days) with a specific date, until such time as the goods are guilty of retaining their applicability. This is to allow the elimination of the ringing of the intermediary competition and to reduce the possibility of vindication of claims from the side of the controlling bodies.
Detailing is not available?
The assistant at the description of the ob'єkta zakupіvlі from the technіchny manager on the delivery of the goods having installed specific vimogi to the product, yogo rozmіrіv, packaging and vіdvantazhennya. What is the right deputy?
As in the previous situation, the zamovnik can establish details and concretizations before the object of purchase, as if he does not attract the exchange of competition among the participants in the auction. Vіdpovіdno to st. 17 135-FZ pіd hour of holding state tenders should be protected by antimonopoly legislation, yakі zaboronyat zdіysnyuvati dії, yakshcho stench can lead to the reduction of competition. It is important to the savage type that it is necessary to have two goods spring pickers or post-employees, then the description is correct and does not avenge the sign of competition. And from now on, I’ll describe all the sukupnіst of details, but it’s more than zastosovna to one whole specific product, then there may be unfair competition and signs of violation of the law.
Availability of GOSTs for the presence of technical characteristics
The deputy, when describing the object of purchase from the technical manager, referred to the normative and technical documents (GOSTs, SNiPi) and did not indicate any specific technical characteristics and indications of the quality of the TRU. What is the right of the deputy to restore power to TRU in such a way?
Application for guests, BNiP and other regulatory and technical documents in tender documentation in fact, they don’t install ostentatious acts, pov'yazanі z vznachennym vіdpovіdnostі vіkonuvanih robіt, serfs, scho nadayutsya needs of the deputy, є є damaged h. 1 tbsp. 33 44-FZ.
In this situation, the deputy is not guilty of restoring the power to the technical manager in such a way. Zamovnik has the right to send to DSTU and BNiP, but only as normative and technical documents to carry out all the necessary assistance to TRU and indicators of their quality.
The legislation on state purchases does not transfer the fence to the installation, it was possible for the compliance of the TRU with the first normative and technical documents, which have all the necessary assistance to them and the indications of the same technical characteristics. The positions of control and judicial authorities are reviewed from the source.
Buvayut vypadki, if the FAS recognizes the statements on the guests, BNIP and other regulatory and technical documents are illegal. Arbitration judges, as a rule, such statements are recognized as rightful, only as normative and technical documents can be used as necessary indications of quality, as well as help to comrades, work, services from those who look at vimiryuvanih values.
Take a distance online course
Vіdpovidno to the Civil Code Russian Federation the term of applicability is the term, after the completion of which the goods become unacceptable for recognition for recognition. At that very hour, the seller was bound to hand over the goods in such a way that the buyer could win the purchase until the end of the term of attachment.
In general, the guarantee has been transferred to the DC of the Russian Federation, it is impossible to defend the purchase by the whole world, so call the parties to the contract to close the mind for a minimum period of an hour, which is completed until the end of the term of appurtenance, so the titles of the superfluous term of applicability. It is not the fault of any state power purchases of medical supplies. For the sovereign deputy, it’s important that the doctor’s money, which should reach the liqual mortgages, could be victorious as much as possible for a long time, so that, at his own hand, he will save the economy of budgetary expenses.
Nasampered, it is necessary to understand that there is a commodity, the term of appurtenance is not passing by, є akіsnim. Tse apparently vplyvaє and on the nature of the violation of the position of the sovereign contract about the term of appurtenance. For damage, I could about the redundant term of appurtenance not zastosovnі provisions of Art. 475 of the Civil Code of the Russian Federation about the transfer of goods to the goods of non-necessary yakost. Those same costs and penalties, transferred by contract. So, in one of the documents, the sovereign’s deputy, trying to get a contract from the post-employee, who put the drug preparations with the term of appurtenance to a lesser excess, the forfeit for damage could be as much as possible. The court has determined that the term is attached to itself according to its own characteristics of the goods: the protyag of the term is attached to the goods for vikoristannya, і lіkarsky preparation, zokrema, zberіgaє all svoї yakіsnі characteristics.
Vіdsotkiversus. specific time period
One of the first meals, as if blaming the sovereign deputy in the course of rozroby auction documentation: how to insert a redundant term of appurtenance. There are only two fundamentally different ones, one type of one option: a redundant term of appurtenance, expressions in vіdsotkakh in the term of applicability, inserted by the generalist, or a term of applicability, expressions of a specific period or date.
Previously, the antimonopoly authorities were unable to give the streamer a position on the establishment of the term of applicability in the cities. Such a way for most of the vipadkivs is not recognized by the mind, which is between competition (divine example: decision of the Irkutsk OFAS Russia issued on 10/16/2013 No. 803).
However, in the middle of 2014 wiyshov sheet of the Federal Antimonopoly Service of Russia with clarifications on food (sheet of the Federal Antimonopoly Service of Russia dated August 26, 2014 No. AK / 34487/14). In the new antimonopoly body, it has given a negative rating to the term of the applicability of medicinal products, which has been introduced in the cities. On її dumku, tse mozhuvat konkurentsіyu pіd іn the hour of zakupіvlі drug preparations.
The FAS of Russia illustrated its position with the simplest butt. It is acceptable that two postal workers take part in the auction. The first proponuє drug preparation with the term of the drug's affinity is 3 years. The other is 2 rocks. In the auction documentation, the zamovnik presents the possibility of a redundant term of appurtenance of at least 70% of the installed one. In this rank, participant 1 will be guilty of putting the drug, until the end of the term of applicability, it is no less than 2.1 years old, participant 2 - no less than 1.4 years old, which will lead to competition. As an alternative to the Federal Antimonopoly Service of Russia, having given recommendations to deputies to establish the term of applicability to a specific period or date. For example, a redundant term of appurtenance - 1.5 times, as a term of applicability medicinal preparation guilty of ending no earlier than 11.2016 p. In connection with the cim, it is immediately significant that in the rest of the period the term of applicability will end on November 31, 2016, the same interpretation of the term of applicability will be introduced in judicial practice(Praise of the Thirteenth Arbitration Court of Appeal dated April 28, 2014 at reference No. A56-80790/2013).
However, this position of the Federal Antimonopoly Service of Russia does not reflect the nature of the superfluous term of applicability. As it was meant to be, the medicinal preparation is left behind at the borders of the term of admissibility, and the shortest term of admissibility, the term of admissibility, is close to the absolute expression, at times a short period of time, with a stretch of such a medicinal product, it can be realized.
At the link with the cim, appointments, the sheet of the FAS Russia is not used as a guideline not only for judicial authorities (the Eighth Arbitration Court of Appeal issued on 17.07.2015 No. 08AP-5942/2015 in reference No. A75-13497/2014), Federal Antimonopoly Service of Russia (div. for example: decision of the Murmansk OFAS of Ukraine issued on September 12, 2014 at reference No. 06-10 / 14-302, decision of the Kurgan Office of the Federal Antimonopoly Service of Russia No. 05-02 / 111-14 issued on 09.06.2014). In any case, judge, so the antimonopoly authorities come out of the fact that the “exclusive” term of appurtenance did not call for the exchange of competition and reasoning with the needs of the deputy.
Okremo varto return respect for the final application. Even more often, in addition to the superfluous term of appurtenance in vіdsotkakh, the substitute for differentiation is stale in terms of the term of applicability (for example, as the term of applicability is 3 years, then the superfluous term of appurtenance is 70% of the established term, as the term is superfluous, the tone is 5 accessories - 60% of installed). And here at the applicant's obov'yazkovo it is necessary to specify the term of applicability, insertion by the clerk, otherwise it is impossible for the deputy to evaluate the validity of the application to the authorities.
In this aspect, there is one more significant problem: the only one is the term of appurtenance. Irrespective of those that, in practice, it is rarely reported, as much as possible is the situation, if the participant in the applicant indicates an excess term of appurtenance in vіdsotkakh, wanting to insert a specific date in the auction documentation. Shvidshe for everything, in this case, you will be allowed to be admitted to the auction, especially, as the documentation directly states the need to win over the loneliness of themselves alone. At the same time, it seems that it is possible for a judge to be listed in court order, shards judge less formally to such inconsistencies and analyze the real possibility of taking part in the auction.
specificsversus. insignificance
per fire rule, inserted n. 3 h. 3 Article. 66 Law No. 44-FZ, in the first part of the application, specific indications are assigned, which confirm the values established by the auction documentation. In this case, the participant in the application must indicate a specific extra term of applicability (div. for example: decision of the Novosibirsk OFAS Russia No. 08-01-427 issued on 11/17/2014).
However, after the court decisions, it is necessary to certify about those who have a permit for a given formal basis, which is inadmissible. Zokrema, the court appoints, which the applicant has not appointed, as a kind of rank of imposition of an excess term on the goods in the range of 60% to 100% (replacement of a specific indicator of the excess term on the appendage) negatively impacts on the quality of the goods or the employer’s contract.
The situation is analogous. So, for example, in the auction documentation, it may be directly stated that the term of applicability of a medicinal product may be irrelevant (not less than X months). At tsomu vpadku itself in such a rank of terminology and maє buti appointments in the applicant. In a different way, regardless of those that the terms of applicability will be included in the range of appointments by the applicant, the replacements will sound at the admission to the auction, and the position will be supported by the antimonopoly authority.
Vrakhovyuchi super-efficient practice that has developed, for the method of establishing a superfluous term of appurtenance on the medical background, it is important for the sovereign (municipal) deputy in the auction documentation to fix it at any given date or period. At that very hour, as a substitute for the appeals of the vіdsotkovy variant, under the hour of the administrative court, it is necessary to bring the court review, which has led to the fringing of competition.
Participants of the auction, at their own discretion, must respectfully auction documentation and when forming the application, protect all the substitutes according to the method of establishing the term of applicability of the medicinal product.
Shadrin Oleksiy Dmitrovich,
young lawyer of the law firm "BRACE"