Who did the research that was used to compare Enlafax with other brands?
Trudi Webber made this Official Information request to Pharmaceutical Management Agency
The request was successful.
From: Trudi Webber
Dear Pharmaceutical Management Agency,
I have read the information provided by Medsafe quoting all the research facts and figures regarding Enlafax, however it does not clearly state who did the research. Could you please tell me who and where the research was done? Was it research that the company selling the drug did or was it confirmed by independent researchers. This question should be answerable without breaking any confidence as it is not requesting how the product was made but how the research was conducted.
Yours faithfully,
Trudi Webber
From: Web Enquiry
Pharmaceutical Management Agency
Hi Trudi
Thank you for your email regarding the research that was used to compare Enlafax with other brands.
This email is to acknowledge that your request for information will be treated as such under the Official Information Act (1982). Your request is currently being worked on and we will have a reply to you as soon as possible and no later than the due date of 7 June 2018.
Kind regards
Katie
PHARMAC
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From: Web Enquiry
Pharmaceutical Management Agency
Hi Trudi
Please find attached PHARMAC’s respond to your recent OIA request.
Kind regards
Katie
PHARMAC
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Pharmaceutical Management Agency
Dear Ms Webber
Thank you for your request for official information, received by the
Ministry of Health on 16 May 2018. The Ministry's reference number for
your request is: H201803736.
You requested:
"Could you please tell me who and where the research was done? Was it
research that the company selling the drug did or was it confirmed by
independent researchers. This question should be answerable without
breaking any confidence as it is not requesting how the product was made
but how the research was conducted."
Your request has been logged and you can expect a reply no later than 14
June 2018 as required under the Official Information Act 1982.
Please note that a working day is defined in the Act as ‘any day of the
week other than a Saturday, Sunday, Good Friday, Easter Monday, Anzac Day,
Labour Day, the Sovereigns birthday, Waitangi Day and a day in the period
commencing 25 December in any year and ending 15 January in the following
year.
If a large amount of information has been requested or if the Ministry
needs to consult in order to make a decision, we may need to extend this
date (this is provided for in section 15A of the Act). We will advise you
if such an extension is necessary.
Yours sincerely,
Maima Koro
Advisor
[email address]
Ministerial Services l Government Services l Office of the Director
General
[1]http://www.health.govt.nz
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References
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Pharmaceutical Management Agency
Dear Ms Webber,
I refer to your official information request received by the Ministry of
Health on 16 May 2018 which was transferred from PHARMAC. To ensure the
Ministry responds to your request appropriately, can you please clarify
whether you are referring to information to support the registration of
Enlafax or the data relating to adverse event reporting.
It will be helpful if you could please provide the specific quote from
Medsafe you are refering to.
Kind regards
Maima
Ministerial Services (OIA)
[email address]
Government Services
Office of the Director-General
Ministry of Health
[1]www.health.govt.nz
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From: Trudi Webber
Dear Pharmaceutical Management Agency,
In response to your query, my main questions "Could you please tell me who and where the research was done? Was it research that the company selling the drug did or was it confirmed by independent researchers?" are in relationship to the information provided by Medsafe -
http://www.medsafe.govt.nz/profs/Datashe...
which is their information sheet about Enlafax, on their website.
Yours faithfully,
Trudi Webber
Pharmaceutical Management Agency
Dear Ms Webber,
Kindly note the Ministry is awaiting your clarification please on your
request.
Kind regards
Maima
Ministerial Services (OIA)
[email address]
Government Services
Office of the Director-General
Ministry of Health
[1]www.health.govt.nz
From: OIA Requests/MOH
To: [FOI #7784 email],
Cc: OIA Requests/MOH@MOH
Date: 18/05/2018 04:19 p.m.
Subject: Clarification of your request: H201803736
Sent by: Maima Koro
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