Israel only accepts MAA from U.S, CAN, SWiss, EU, Japan, Aus
Nov 15, 2015 14:58:00 GMT -5
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Post by lakers on Nov 15, 2015 14:58:00 GMT -5
10. Are foreign marketing authorisations recognised in your juris- diction? if so, please briefly outline the recognition procedure.
There is no recognition of foreign marketing authorisations as such. However, the Administration only accepts applications for registration of Preparations that already possess marketing au- thorisations from any of the following countries, and are actually marketed in them (Recognised Countries):
The US.
Canada.
Any EU member state that joined the EU before May 2004.
Switzerland, Norway, Iceland, Australia, New Zealand and Japan.
www.s-horowitz.co.il/Media/Files/1a8d7187-509f-4971-9576-2e78a80acae0.pdf
Country Q&A Israel
8. Please give an overview of the authorisation process to mar-
ket medicinal products. in particular:
to which authority must the application be made?
what conditions must be met to obtain authorisation?
what are the key stages and timing?
what fee must be paid?
How long does authorisation last and what is the renewal procedure?
Registration of a Preparation in the Registry is a pre-condition for marketing, as well as manufacturing or prescribing it. Specific ex- ceptions to the registration duty, which are subject to the Admin- istration’s approval, are listed in the Pharmacists Regulations.
Application
Application should be made to the Registration Department with- in the Administration.
Conditions
The basic requirements are:
Marketing authorisation from a Recognised Country (see
Question 10).
Standardisation Institute certificate confirming the adequate
quality of the Preparation.
Evidence of safety.
Evidence as to efficacy.
The commercial name of the Preparation is not misleading. Evidence of GMP.
Restrictions on foreign applicants
An application can only be filed on behalf of an Israeli citizen or corporate body, and only by a responsible pharmacist possessing an appropriate permit. For this reason, most foreign Preparation manufacturers operate through an Israeli subsidiary and employ a responsible pharmacist (who may be a freelancer), or appoint a local importer to act as their agent, for registration purposes.
Key stages and timing
Under MOH guidelines, registration of a new Preparation should be completed within 360 days (all timeframes specified in MOH guidelines exclude waiting time for applicant’s replies).
Following registration, the applicant must submit a first batch of the Preparation, its packaging and the final version of the con- sumer and prescription information for inspection before market- ing it. Marketing is subject to each batch of the Preparation being inspected in advance by the Standardisation Institute or by a recognised laboratory, as applicable.
fee
The following fees apply:
Registration of a single Preparation: NIS5,599 (about US$1,500).
MARKeting
Standardisation Institute certificate: NIS3,072 (about US$800) for an imported Preparation, NIS2,294 (about US$600) for a locally manufactured Preparation.
Batch quality test for registration renewal: NIS1,209 (about US$320).
Renewal fee: NIS1,119 (about US$300). Period of authorisation and renewals
Registration is valid for five years, after which the authorisation can be renewed for further periods of five years each.
If the registration is not renewed, the marketing of existing stocks of Preparations can continue for up to one year following expira- tion (unless the MOH directs otherwise).
9. Please briefly outline the abridged procedure for obtaining marketing authorisations for medicinal products. in particular:
which medicinal products can benefit from the abridged procedure (for example, generics)?
what conditions must be met?
what procedure applies and what information can the ap-
plicant rely on?
An applicant seeking to register a generic Preparation is exempt- ed from providing evidence of safety and efficacy, provided that bioequivalence and quality are established.
An abridged registration procedure is available for generic Prepa- rations which already possess marketing authorisations from the US Food and Drug and Administration (FDA) or the European Medicines Agency (EMEA). If no objection is made by the MOH, the registration procedure for these Preparations will be com- pleted within 70 days.
Under the Administration guidelines, the registration procedure of a new dosage for an already registered Preparation will be completed within 180 days (excluding waiting time for the ap- plicant’s response, and provided that the original file meets the standards applicable on the date of submission and is identical to the submitted file, subject to necessary modifications). Prepa- rations newly included in the Health Package enjoy preferential treatment as far as waiting time for examination is concerned.
www.lymphomacoalition.org/docman2/leip-reports/leip-2013/339-israel-regulatory-and-funding-process-flowcharts-october-2013/file
Decisions on which drugs are added to the Health Basket are made once a year
Applicant submits application to Pharmaepidemiologics and Drug Economics Department
Pharmaepidemiologics and Drug Economics Department conducts assessment and makes reimbursement recommendation
Ministry of Health makes final reimbursement decision and drug is added to the National Health Basket
m.jpost.com/Israel-News/Health-basket-panel-head-calls-for-doubling-annual-increase-413954#article=10392OTVDNjgxOUE5RTQ3ODI0QjU3Q0ZGQTE1NDUxREE5MzU=
Health basket panel head calls for doubling annual increase
By JUDY SIEGEL-ITZKOVICH
Tue, 01 Sep 2015, 03:12 PM
Halevy: If the public system doesn’t cover vital drugs, I will certainly consider buying private insurance.
Photo by: INGIMAGE / ASAP
Prof. Jonathan Halevy, chairman of the Health Basket Committee, on Tuesday called to double the annual increase to the budget of the basket.
Speaking at a Tel Aviv Pharma-Israel conference, Halevy, who is also director-general of Shaare Zedek Medical Center, said that doubling the annual increase from NIS 300 million – where it has been set by the Treasury for the past three years – to NIS 600 million can improve the healthcare situation “tremendously” by covering more of the cost of medical technologies provided to Israelis.
“I think that the dilemma we’ve had in recent years about [cancer] drugs that extend life for two or three months will also occur regarding drugs that enable patients to live six months to a year longer if the basket doesn’t grow [by more than just NIS 300 million]. But even if this does occur, important drugs will still remain outside the basket.”
The basket includes all of the drugs and medical technologies that the Treasury, via the four health funds, subsidizes. The committee consists of doctors, medical ethicists, Treasury and Health Ministry officials, health fund executives, and public representatives who volunteer for the job every year.
The Treasury alone decides how much the basket will expand, instead of enacting an automatic annual increase. Halevy, who has said that heading the committee has been one of the most challenging and interesting posts he has ever held, told The Jerusalem Post that he would recommend an automatic increase, but he doubts that Finance Ministry officials would forgo their decisionmaking power.
He added that while most of the relevant life-saving drugs are for treating cancers, additional medications and technologies to address a variety of other diseases should be added to the basket.
On an optimistic note, Halevy, an internal medicine and liver specialist by training, said he hoped that manufacturers and importers of drugs that can cure the often-fatal hepatitis C will lower their prices so that more carriers of the virus will be eligible for treatment.
“Members of the committee have been forced to give up on certain technologies that everyone felt were important to fight for,” Halevy added.
Asked whether he himself has private medical insurance, or if not, whether he planned to get such a policy, the veteran medical administrator said: “I have not needed private insurance so far, but if the public system doesn’t cover vital drugs, I will certainly consider buying private insurance. But I don’t believe that will happen.”
Asked whether he supported the position of Deputy Health Minister Ya’acov Litzman to restore life-saving drugs not in the basket to the public health funds’ supplementary health insurance policies, Halevy said, “Rabbi Litzman has proven himself as one who finds solutions to impossible problems. If he succeeds in adding life-saving drugs to supplementary policies and makes sure that the poor who have no such coverage get them too, he will indeed prove that he has a magic touch.”
Edith Chernovich, director-general of Pharma-Israel (an organization of local research- and development- based pharmaceutical companies) said, “We are at a dramatic stage in the development of original drugs. Pharmaceutical innovation creates drugs that treat and cure patients, saving lives and significantly improving quality of life. To keep up with the pace of development, there is no choice but to update the basket by 2 percent each year, as is customary in developed countries with public health systems.”
Economy Minister Arye Deri said at the conference that the country can turn into a Silicon Valley in the field of pharmaceuticals. “The government gave me the responsibility for preparing a plan for the development of the north within six months, and we regard the pharmaceutical field as one of the building blocks of this program.”
There is a problem with bureaucracy and irrelevant legislation, notes Deri. “Too much regulation can deter companies from carrying out clinical trials. We will deal with this.”
US Ambassador Dan Shapiro reported that he has held many meetings with officials from US pharmaceutical companies that operate out of Israel. “They will continue to regard Israel as a partner and be active here,” he said. “They will continue to expand the number of their employees here. We are pleased that they are here, but there are regulatory challenges that prevent them from expanding more.”
There is no recognition of foreign marketing authorisations as such. However, the Administration only accepts applications for registration of Preparations that already possess marketing au- thorisations from any of the following countries, and are actually marketed in them (Recognised Countries):
The US.
Canada.
Any EU member state that joined the EU before May 2004.
Switzerland, Norway, Iceland, Australia, New Zealand and Japan.
www.s-horowitz.co.il/Media/Files/1a8d7187-509f-4971-9576-2e78a80acae0.pdf
Country Q&A Israel
8. Please give an overview of the authorisation process to mar-
ket medicinal products. in particular:
to which authority must the application be made?
what conditions must be met to obtain authorisation?
what are the key stages and timing?
what fee must be paid?
How long does authorisation last and what is the renewal procedure?
Registration of a Preparation in the Registry is a pre-condition for marketing, as well as manufacturing or prescribing it. Specific ex- ceptions to the registration duty, which are subject to the Admin- istration’s approval, are listed in the Pharmacists Regulations.
Application
Application should be made to the Registration Department with- in the Administration.
Conditions
The basic requirements are:
Marketing authorisation from a Recognised Country (see
Question 10).
Standardisation Institute certificate confirming the adequate
quality of the Preparation.
Evidence of safety.
Evidence as to efficacy.
The commercial name of the Preparation is not misleading. Evidence of GMP.
Restrictions on foreign applicants
An application can only be filed on behalf of an Israeli citizen or corporate body, and only by a responsible pharmacist possessing an appropriate permit. For this reason, most foreign Preparation manufacturers operate through an Israeli subsidiary and employ a responsible pharmacist (who may be a freelancer), or appoint a local importer to act as their agent, for registration purposes.
Key stages and timing
Under MOH guidelines, registration of a new Preparation should be completed within 360 days (all timeframes specified in MOH guidelines exclude waiting time for applicant’s replies).
Following registration, the applicant must submit a first batch of the Preparation, its packaging and the final version of the con- sumer and prescription information for inspection before market- ing it. Marketing is subject to each batch of the Preparation being inspected in advance by the Standardisation Institute or by a recognised laboratory, as applicable.
fee
The following fees apply:
Registration of a single Preparation: NIS5,599 (about US$1,500).
MARKeting
Standardisation Institute certificate: NIS3,072 (about US$800) for an imported Preparation, NIS2,294 (about US$600) for a locally manufactured Preparation.
Batch quality test for registration renewal: NIS1,209 (about US$320).
Renewal fee: NIS1,119 (about US$300). Period of authorisation and renewals
Registration is valid for five years, after which the authorisation can be renewed for further periods of five years each.
If the registration is not renewed, the marketing of existing stocks of Preparations can continue for up to one year following expira- tion (unless the MOH directs otherwise).
9. Please briefly outline the abridged procedure for obtaining marketing authorisations for medicinal products. in particular:
which medicinal products can benefit from the abridged procedure (for example, generics)?
what conditions must be met?
what procedure applies and what information can the ap-
plicant rely on?
An applicant seeking to register a generic Preparation is exempt- ed from providing evidence of safety and efficacy, provided that bioequivalence and quality are established.
An abridged registration procedure is available for generic Prepa- rations which already possess marketing authorisations from the US Food and Drug and Administration (FDA) or the European Medicines Agency (EMEA). If no objection is made by the MOH, the registration procedure for these Preparations will be com- pleted within 70 days.
Under the Administration guidelines, the registration procedure of a new dosage for an already registered Preparation will be completed within 180 days (excluding waiting time for the ap- plicant’s response, and provided that the original file meets the standards applicable on the date of submission and is identical to the submitted file, subject to necessary modifications). Prepa- rations newly included in the Health Package enjoy preferential treatment as far as waiting time for examination is concerned.
www.lymphomacoalition.org/docman2/leip-reports/leip-2013/339-israel-regulatory-and-funding-process-flowcharts-october-2013/file
Decisions on which drugs are added to the Health Basket are made once a year
Applicant submits application to Pharmaepidemiologics and Drug Economics Department
Pharmaepidemiologics and Drug Economics Department conducts assessment and makes reimbursement recommendation
Ministry of Health makes final reimbursement decision and drug is added to the National Health Basket
m.jpost.com/Israel-News/Health-basket-panel-head-calls-for-doubling-annual-increase-413954#article=10392OTVDNjgxOUE5RTQ3ODI0QjU3Q0ZGQTE1NDUxREE5MzU=
Health basket panel head calls for doubling annual increase
By JUDY SIEGEL-ITZKOVICH
Tue, 01 Sep 2015, 03:12 PM
Halevy: If the public system doesn’t cover vital drugs, I will certainly consider buying private insurance.
Photo by: INGIMAGE / ASAP
Prof. Jonathan Halevy, chairman of the Health Basket Committee, on Tuesday called to double the annual increase to the budget of the basket.
Speaking at a Tel Aviv Pharma-Israel conference, Halevy, who is also director-general of Shaare Zedek Medical Center, said that doubling the annual increase from NIS 300 million – where it has been set by the Treasury for the past three years – to NIS 600 million can improve the healthcare situation “tremendously” by covering more of the cost of medical technologies provided to Israelis.
“I think that the dilemma we’ve had in recent years about [cancer] drugs that extend life for two or three months will also occur regarding drugs that enable patients to live six months to a year longer if the basket doesn’t grow [by more than just NIS 300 million]. But even if this does occur, important drugs will still remain outside the basket.”
The basket includes all of the drugs and medical technologies that the Treasury, via the four health funds, subsidizes. The committee consists of doctors, medical ethicists, Treasury and Health Ministry officials, health fund executives, and public representatives who volunteer for the job every year.
The Treasury alone decides how much the basket will expand, instead of enacting an automatic annual increase. Halevy, who has said that heading the committee has been one of the most challenging and interesting posts he has ever held, told The Jerusalem Post that he would recommend an automatic increase, but he doubts that Finance Ministry officials would forgo their decisionmaking power.
He added that while most of the relevant life-saving drugs are for treating cancers, additional medications and technologies to address a variety of other diseases should be added to the basket.
On an optimistic note, Halevy, an internal medicine and liver specialist by training, said he hoped that manufacturers and importers of drugs that can cure the often-fatal hepatitis C will lower their prices so that more carriers of the virus will be eligible for treatment.
“Members of the committee have been forced to give up on certain technologies that everyone felt were important to fight for,” Halevy added.
Asked whether he himself has private medical insurance, or if not, whether he planned to get such a policy, the veteran medical administrator said: “I have not needed private insurance so far, but if the public system doesn’t cover vital drugs, I will certainly consider buying private insurance. But I don’t believe that will happen.”
Asked whether he supported the position of Deputy Health Minister Ya’acov Litzman to restore life-saving drugs not in the basket to the public health funds’ supplementary health insurance policies, Halevy said, “Rabbi Litzman has proven himself as one who finds solutions to impossible problems. If he succeeds in adding life-saving drugs to supplementary policies and makes sure that the poor who have no such coverage get them too, he will indeed prove that he has a magic touch.”
Edith Chernovich, director-general of Pharma-Israel (an organization of local research- and development- based pharmaceutical companies) said, “We are at a dramatic stage in the development of original drugs. Pharmaceutical innovation creates drugs that treat and cure patients, saving lives and significantly improving quality of life. To keep up with the pace of development, there is no choice but to update the basket by 2 percent each year, as is customary in developed countries with public health systems.”
Economy Minister Arye Deri said at the conference that the country can turn into a Silicon Valley in the field of pharmaceuticals. “The government gave me the responsibility for preparing a plan for the development of the north within six months, and we regard the pharmaceutical field as one of the building blocks of this program.”
There is a problem with bureaucracy and irrelevant legislation, notes Deri. “Too much regulation can deter companies from carrying out clinical trials. We will deal with this.”
US Ambassador Dan Shapiro reported that he has held many meetings with officials from US pharmaceutical companies that operate out of Israel. “They will continue to regard Israel as a partner and be active here,” he said. “They will continue to expand the number of their employees here. We are pleased that they are here, but there are regulatory challenges that prevent them from expanding more.”