Dear Virginia
In answer to your OIA request, I have been asked to respond directly.
In New Zealand Pre-marketing approval must be obtained for new and changed
medicines. New medicines cannot be marketed in New Zealand without the
consent of the Minister of Health. This is the Section 23 approval in the
list below.
Medicines to which changes have been made cannot be marketed without the
consent of the Director-General of Health. Data that satisfactorily
establish the quality, safety and efficacy of the product, for the
purposes for which it is to be used, must be submitted for evaluation
before consent can be granted.  These are the other items in the list.
Please don't hesitate to contact me if you have any further queries.
Kind regards
Becci

--------------------------------------------------------------------------

From: OIA Requests <[email address]>

Sent: Thursday, 14 October 2021 8:52 am
To: Emily Drummond <[email address]>
Subject: Fw: Official Information request - Please explain the meaning of
the Latest Regulatory Activity

 

Hey Emily,

 

Can this be a direct reply from Medsafe please? 

 

Thanks

Alex

 

------------------------------------------------------------------------

From: Virginia Crawford
<[1][FYI request #17177 email]>
Sent: Wednesday, 13 October 2021 19:54
To: OIA Requests <[2][email address]>
Subject: Official Information request - Please explain the meaning of the
Latest Regulatory Activity

 

Dear Ministry of Health,

Could you please give explanatory details of the following:

Latest Regulatory Activity
Application Date        Application Type        Change(s)       Status 
Payment Date    Priority
7/10/2021       Changed Medicine Notification   Active ingredient
manufacturing site    Awaiting payment          
6/10/2021       Changed Medicine Notification   Finished product
manufacturing site; Finished product secondary packing site; Finished
product testing site     Awaiting payment          
16/9/2021       Changed Medicine Notification   Finished product
manufacturing site; Finished product secondary packing site; Finished
product testing site     Information requested 12/10/2021       
22/9/2021       
2/9/2021        Changed Medicine Notification   Finished product
manufacturing site; Finished product secondary packing site; Finished
product testing site     Information requested 20/9/2021 15/9/2021       
31/8/2021       Changed Medicine Notification   Excipient
specifications/test methods - Grade 2 Additional evaluation started
11/10/2021        8/9/2021        
30/8/2021       Changed Medicine Notification   Test methods and
specifications - Grade 4; Test methods and specifications - Grade 5   
Initial evaluation      8/9/2021        
27/8/2021       Changed Medicine Notification   Active ingredient
manufacturing site    Information requested 28/9/2021 1/9/2021        
26/8/2021       Changed Medicine Notification   Excipient
specifications/test methods - Grade 2 Information requested 23/9/2021
8/9/2021        
16/8/2021       Changed Medicine Notification   Formulation - Grade 1;
Change in ownership      Evaluation complete     25/8/2021       
13/11/2020      Provisional Consent (Section 23)        New higher-risk
medicine containing one or more new active substances   Granted
3/2/2021        25/11/2020      Y

I found the above on the following website

[3]https://www.medsafe.govt.nz/regulatory/P...

Yours faithfully,

Virginia Crawford

-------------------------------------------------------------------

This is an Official Information request made via the FYI website.

Please use this email address for all replies to this request:
[4][FYI request #17177 email]

Is [5][Ministry of Health request email] the wrong address for Official Information
requests to Ministry of Health? If so, please contact us using this form:
[6]https://scanmail.trustwave.com/?c=15517&...

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[7]https://scanmail.trustwave.com/?c=15517&...

If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.

show quoted sections

This e-mail message has been scanned for Viruses and Content and cleared
by the Ministry of Health's Content and Virus Filtering Gateway

--------------------------------------------------------------------------

References

Visible links
1. mailto:[FYI request #17177 email]
2. mailto:[email address]
3. https://www.medsafe.govt.nz/regulatory/P...
4. mailto:[FYI request #17177 email]
5. mailto:[Ministry of Health request email]
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...

Dear Virginia
I'm sorry I am not quite sure what you are after.  Do you have a number I
could call you on to clarify?
Many thanks
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FYI request #17177 email]>
Sent: Thursday, 14 October 2021 5:14 PM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

You have not given me a satisfactory reply to my request.  Not by a long
shot!

Please explain EACH AND EVERY entry (by which I mean ITEMISED entry) of
each changed medicine notification.

Yours sincerely,

Virginia Crawford

show quoted sections

Dear Virginia
Here is the first entry for example

Provisional New higher-risk medicine Granted
13/11/2020 Consent (Section containing one or more 3/2/2021 25/11/2020 Y
23) new active substances

This is Medsafe receiving the application for Comirnaty on 13 November
2020 and it shows it was granted on 3 February 2021
Is that what you are after for each line?
Kind regards
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FOI #17177 email]>
Sent: Thursday, 14 October 2021 8:36 PM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

Perhaps my layout wasn't the best.  If you go to this page:

[1]https://www.medsafe.govt.nz/regulatory/P...

and scroll down to the bottom - Latest Regulatory Activity

I wish to have an explanation for each of the entries in that table.

Yours sincerely,

Virginia Crawford

show quoted sections

Dear Virginia
I hope this is what you are looking for:

Application Application Change(s)  Status  Payment Priority   
Date  Type  Date 
8/10/2021  Provisional Renewal of Awaiting       Sponsor has
Renewal  provisional payment  submitted
consent  their
Application
for renewal of
their
Provisional
Consent and it
is awaiting
payment 
7/10/2021  Changed Active ingredient Initial 13/10/2021     Sponsor has
Medicine manufacturing site  evaluation  submitted a
Notification  new active
ingredient
manufacturing
site this
under
evaluation 
6/10/2021  Changed Finished product Initial 13/10/2021     Sponsor has
Medicine manufacturing site; evaluation  submitted a
Notification  Finished product new
secondary packing manufacturing
site; Finished site, packing
product testing site and
site  product
testing site,
this is under
evaluation 
16/9/2021  Changed Finished product Information 22/9/2021     Sponsor has
Medicine manufacturing site; requested submitted a
Notification  Finished product 12/10/2021  new
secondary packing manufacturing
site; Finished site, packing
product testing site and
site  product
testing site,
this is under
evaluation 
2/9/2021  Changed Finished product Additional 15/9/2021     Sponsor has
Medicine manufacturing site; evaluation submitted a
Notification  Finished product started new
secondary packing 13/10/2021  manufacturing
site; Finished site, packing
product testing site and
site  product
testing site,
this is under
evaluation 
30/8/2021  Changed Test methods and Initial 8/9/2021     This is a list
Medicine specifications - evaluation  of test
Notification  Grade 4; Test methods and
methods and specifications
specifications - that the
Grade 5  product should
conform to in
order to be
considered
acceptable for
its intended
use. 

When tested
according to
the listed
test methds,
will meet the
listed
acceptance
criteria.
Specifications
are critical
quality
standards that
are proposed
and justified
by the
manufacturer
and approved
by regulatory
authorities as
conditions of
approval. 
27/8/2021  Changed Active ingredient Information 1/9/2021     Information
Medicine manufacturing site  requested requested as
Notification  28/9/2021  part of the
Conditions 
26/8/2021  Changed Excipient Information Information
Medicine specifications/test requested requestion as
Notification  methods - Grade 2  23/9/2021  part of the
Conditions 

Kind regards
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FOI #17177 email]>
Sent: Friday, 15 October 2021 11:34 AM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

Yes, it is.  However you may ignore similar (duplicate) entries.

Yours sincerely,

Virginia Crawford

show quoted sections

Dear Virginia
It is in a table which must have corrupted after it has been sent.  Please
find a pdf attached.
Kind regards
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FOI #17177 email]>
Sent: Friday, 15 October 2021 12:26 PM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

Did you proof read your reply?  I suggest you rewrite it with some decent
paragraphing, as currently it's pretty much unreadable. Thank you.

Yours sincerely,

Virginia Crawford

show quoted sections

Dear Virginia
Test Methods and Specifications
Provide sufficient validation data to show that the pharmacopoeial test
methods used to control a finished product, to confirm that the test
methods work satisfactorily for the product concerned
Finished product manufacturing site; Finished product secondary packing
site; Finished product testing site
Provide documents to show that the medicine is Manufactured, packed and
tested to an appropriate standard.  For example a GMP certificate for
Manufacturing.
Kind regards
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FOI #17177 email]>
Sent: Saturday, 16 October 2021 1:44 PM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

Thank you for the information submitted so far.

Could you please supply further details of the entries dated 16/8/21 and
13/11/20

Yours sincerely,

Virginia Crawford

show quoted sections

Der Virginia
My apologies for misunderstanding your request.
13/11/2020      Provisional Consent (Section 23)        New higher-risk
medicine containing one or more new active substances   Granted
3/2/2021        25/11/2020      Y
This is the original application.
16/8/2021       Changed Medicine Notification   Formulation - Grade 1;
Change in ownership      Evaluation complete     25/8/2021 
Add an additional manufacturer/packer of an ingredient and to register a
change in name for an existing manufacturer/packer.
I hope this answers your queries.
Kind regards
Becci

--------------------------------------------------------------------------

From: Virginia Crawford <[FOI #17177 email]>
Sent: Saturday, 16 October 2021 10:21 PM
To: Medsafe <[email address]>
Subject: Re: Fw: Official Information request - Please explain the meaning
of the Latest Regulatory Activity
 
Dear Medsafe,

I don't think that's quite right, is it? You don't seem to be referring to
the entries I requested.  I have to wonder why that is...

The entries I'm referring to are these:

16/8/2021       Changed Medicine Notification   Formulation - Grade 1;
Change in ownership      Evaluation complete     25/8/2021       
13/11/2020      Provisional Consent (Section 23)        New higher-risk
medicine containing one or more new active substances   Granted
3/2/2021        25/11/2020      Y

Yours sincerely,

Virginia Crawford

show quoted sections