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A few days ago, the Zhejiang Provincial Drug Administration issued the "Announcement of Zhejiang Provincial Drug Administration on Implementing the "One Thing" Reform in the Approval of Medical Device Operation"
.
According to the announcement, starting next month, Zhejiang Province will once again open up the approval of pharmacies, and new pharmacies will apply for the "Drug Business License", "Medical Device Business License", and the second-class medical device business record.
You can apply for a one-line settlement.
.
This reform will start on November 1, 2021
.
It is understood that in order to deepen the reform of decentralization
, regulation and service, and to further reduce the time limit for the establishment of pharmaceutical companies, Zhejiang Province had cancelled the approval for the establishment of retail pharmacies as early as last year .
With the exception of Zhejiang Province, relevant policies are currently in Shanghai, Fujian, Heilongjiang, and Liaoning.
Dozens of provinces have begun to implement it
.
For example, in July this year, the Shaanxi Food and Drug Administration issued the "Notice on Issuing the Implementation Plan for Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development of Market Entities" (hereinafter referred to as the "Notice")
.
Among them, the notice It is clearly stated that after the cancellation of the "use of radioactive drugs by medical institutions (Class I and II)", "approval for the establishment of pharmaceutical retail enterprises" and "approval for the establishment of pharmaceutical wholesale enterprises" in the free trade zone, the pilot free trade zone shall apply for the establishment of pharmaceutical wholesale and retail enterprises.
It is no longer necessary to apply to the drug regulatory department for preparatory approval, and you can directly apply for a drug business license
.
The industry believes that the issuance of this document will be a great benefit for pharmacies.
The number of pharmacy certification materials will be greatly reduced, which will effectively shorten the pharmacy approval process improve the efficiency of accreditation
.
It is worth mentioning that, in addition to compression pharmacies run time, the relevant procedures, but in recent years much has issued a document may not have licensed pharmacists temporarily cancel the operating area restrictions, cancel pharmacies spacing, as well as "one industry, one license To reduce the burden of opening pharmacies
.
It is understood that the limited distance of pharmacies has been established for a long time.
In the past, it was to prevent pharmacies from clustering together.
Therefore, many places including Beijing, Shanghai, Tianjin, etc.
The requirements range from 50 meters to 350 meters
.
However, in June this year, the Beijing Municipal Drug Administration issued the "Notice of the Beijing Municipal Drug Administration on Relevant Work on the Approval Reform of Drug Retail Business Licensing (Draft for Solicitation of Comments)"
.
Among them, the "Draft of Opinions" proposes that the restriction on the feasible distance of more than 350 meters between the new drug retail enterprise and the existing drug retail enterprise will be cancelled, and the new drug retail enterprise or the original drug retail enterprise will apply for changes.
For the registered address, the distance from the existing pharmacy will no longer be a condition for permit review
.
In addition, as early as December 1 last year, the Heilongjiang Provincial Drug Administration also issued a notice stating that the approval for the establishment of drug retail chain stores and drug retail enterprises will be cancelled, and the application for opening drug retail chain stores and drug retail stores that only deal in Class B non-prescription drugs will be cancelled.
Enterprises shall implement the notification and commitment system for examination and approval, and shall not set unreasonable conditions such as spacing restrictions on opening pharmacies
.
From an overall point of view, the documents issued by various localities are actually further promoting the approval of pharmacies, reducing restrictions and making it easier to open stores
.
However, some people in the industry have pointed out that "easy to open a store" also means lower barriers to entry, which will intensify market competition while attracting more people to the pharmacy industry
.
Among them, especially for small and medium-sized pharmacies, life will become more and more difficult in the face of the continuous expansion of large-scale chains
.
Therefore, for small and medium pharmacies, it is necessary to accelerate the re-adjustment of product structure based on positioning, extend to service and medical, and continuously improve their competitiveness, in order to obtain more development opportunities and not be easily eliminated
.
.
According to the announcement, starting next month, Zhejiang Province will once again open up the approval of pharmacies, and new pharmacies will apply for the "Drug Business License", "Medical Device Business License", and the second-class medical device business record.
You can apply for a one-line settlement.
.
This reform will start on November 1, 2021
.
It is understood that in order to deepen the reform of decentralization
, regulation and service, and to further reduce the time limit for the establishment of pharmaceutical companies, Zhejiang Province had cancelled the approval for the establishment of retail pharmacies as early as last year .
With the exception of Zhejiang Province, relevant policies are currently in Shanghai, Fujian, Heilongjiang, and Liaoning.
Dozens of provinces have begun to implement it
.
For example, in July this year, the Shaanxi Food and Drug Administration issued the "Notice on Issuing the Implementation Plan for Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development of Market Entities" (hereinafter referred to as the "Notice")
.
Among them, the notice It is clearly stated that after the cancellation of the "use of radioactive drugs by medical institutions (Class I and II)", "approval for the establishment of pharmaceutical retail enterprises" and "approval for the establishment of pharmaceutical wholesale enterprises" in the free trade zone, the pilot free trade zone shall apply for the establishment of pharmaceutical wholesale and retail enterprises.
It is no longer necessary to apply to the drug regulatory department for preparatory approval, and you can directly apply for a drug business license
.
The industry believes that the issuance of this document will be a great benefit for pharmacies.
The number of pharmacy certification materials will be greatly reduced, which will effectively shorten the pharmacy approval process improve the efficiency of accreditation
.
It is worth mentioning that, in addition to compression pharmacies run time, the relevant procedures, but in recent years much has issued a document may not have licensed pharmacists temporarily cancel the operating area restrictions, cancel pharmacies spacing, as well as "one industry, one license To reduce the burden of opening pharmacies
.
It is understood that the limited distance of pharmacies has been established for a long time.
In the past, it was to prevent pharmacies from clustering together.
Therefore, many places including Beijing, Shanghai, Tianjin, etc.
The requirements range from 50 meters to 350 meters
.
However, in June this year, the Beijing Municipal Drug Administration issued the "Notice of the Beijing Municipal Drug Administration on Relevant Work on the Approval Reform of Drug Retail Business Licensing (Draft for Solicitation of Comments)"
.
Among them, the "Draft of Opinions" proposes that the restriction on the feasible distance of more than 350 meters between the new drug retail enterprise and the existing drug retail enterprise will be cancelled, and the new drug retail enterprise or the original drug retail enterprise will apply for changes.
For the registered address, the distance from the existing pharmacy will no longer be a condition for permit review
.
In addition, as early as December 1 last year, the Heilongjiang Provincial Drug Administration also issued a notice stating that the approval for the establishment of drug retail chain stores and drug retail enterprises will be cancelled, and the application for opening drug retail chain stores and drug retail stores that only deal in Class B non-prescription drugs will be cancelled.
Enterprises shall implement the notification and commitment system for examination and approval, and shall not set unreasonable conditions such as spacing restrictions on opening pharmacies
.
From an overall point of view, the documents issued by various localities are actually further promoting the approval of pharmacies, reducing restrictions and making it easier to open stores
.
However, some people in the industry have pointed out that "easy to open a store" also means lower barriers to entry, which will intensify market competition while attracting more people to the pharmacy industry
.
Among them, especially for small and medium-sized pharmacies, life will become more and more difficult in the face of the continuous expansion of large-scale chains
.
Therefore, for small and medium pharmacies, it is necessary to accelerate the re-adjustment of product structure based on positioning, extend to service and medical, and continuously improve their competitiveness, in order to obtain more development opportunities and not be easily eliminated
.
