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TXTM : MEDICINES CONTROL COUNCIL OF S.A.
https://medicalcannabis.co.za/tag/medicines-control-council-of-south-africa/?age-verified=0ae8796de2
TXTM S.A. LAWS ARE BEING UPDATED AS WE WAIT:
MEDICINES AND RELATED SUBSTANCES ACT, 1965 - DRAFT
http://www.gov.za/sites/www.gov.za/files/40577_gon50.pdf
DISPENSING LAWS HAVE ALREADY BEEN UPDATED.
http://www.gov.za/sites/www.gov.za/files/40577_gon48.pdf
Its really happening! THE link actually shows a draft of the laws/ regulation being changed.
Also, be aware that SAHPHRA is going to replace MCC as the regulatory agency in April. my guess is this will have a great effect on fast tracking the products for distribution in S.A.
https://www.businesslive.co.za/bd/companies/healthcare/2017-02-01-efficient-drugs-regulator-will-aid-generic-medicine-manufacturers-bmi-says/
TXTM MCC: Two new sets of regulations
Posted 31 January 2017
The Minister of Health has published two sets of regulations on 27 January 2017
General Regulations to the Medicines and Related Substances Act (GoN 50, GG. 40577, 27 January 2017), for comment by 27 February 20167 according to the gov.za web site, but within 3 months according to the text – http://www.gov.za/sites/www.gov.za/files/40577_gon50.pdf
This is a comprehensive set of proposed regulations to accompany the launch of SAHPRA and allow for the promulgation of the 2008 and 2015 Amendment Acts. The ToC is as follows (and includes 25A. Sub -categories of complementary medicines):
LIST OF CONTENTS
Regulation No. Title
Definitions.
Requirements for therapeutic equivalence.
The manner and conditions for allowing international tendering.
Conditions for compounding medicine.
Time frames for considering applications.
Particulars to be published in the Gazette in respect of applications received for registration in terms of section 14(3).
Importation of medicines in terms of section 15C.
Labelling of medicines intended for human use.
Professional Information for medicines for human use.
Consumer Information,
Prescription book or permanent record.
Importation of medicines into the Republic.
Transmission of medicines through the Republic.
Permits and authorisation in terms of section 22A of the Act.
Importation or exportation of specified Schedule 5. Schedule 6, Schedule 7 or Schedule 8 substances.
Personal medicinal use by persons entering the Republic.
Information to be furnished annually to the Chief Executive Officer.
Licence to dispense or compound and dispense medicines.
Licence to manufacture, import, export, act as a wholesaler or distribute medicines or scheduled substances.
19A. Exemption in terms of Section 22H
Period of validity of licence issued in terms of regulations 18 and 19 and renewal of licences.
Appeal against the decision of the Director -General.
21A. Appeal against the decision of the Authority.
Application for the registration of a medicine.
Information that must appear in the register for medicines.
23A. Transfer from the register for medicines to the register for medical devices or IVDs.
Application for an amendment to the register for medicines.
Categories and classification of medicines.
25A. Sub -categories of complementary medicines.
Certificate of registration.
Destruction of medicines.
Particulars which must appear on a prescription for a medicine.
28A. Particulars which must appear on an order for a Schedule 6 medicine.
Returns to be furnished in respect of specified Schedule 5 and Schedule 6, 7 or 8 substances.
Register of specified Schedule 5 or Schedule 6 medicines.
Method of taking samples, the certificate to be issued and the reporting of analysis results.
Seizure of medicines.
Repackaging of medicines.
Conduct of clinical trials for humans and animals.
34A. Authorisation of sale of unregistered medicine for certain purposes.
Skills of staff of the Authority.
Control of medicines in hospitals.
Vigilance.
Pricing Committee.
Investigations.
Professional information for veterinary medicines.
Labelling for veterinary medicines.
Offences and Penalties.
Compliance with Requirements.
Batch release for biological medicines.
Advertising of medicines.
Obtaining pain control medicines by registered midwives.
Acquisition and use of medicines by masters of ships and officers in charge of any aircraft.
Use of medicines for exhibition purposes.
Repeal.
Commencement.
Medicines and Related Substances Act: Regulations: Transparent pricing system: Dispensing fee for pharmacists (GoN 48, GG. 40577, 27 January 2017) – http://www.gov.za/sites/www.gov.za/files/40577_gon48.pdf
This is the revised dispensing fee for pharmacists, signed by the Minister on 21 December 2016, which stipulates:
” 10. (1) The appropriate dispensing fee as contemplated in Section 22G (2)(b) of the Act to be charged by a pharmacist, must be calculated as
follows:
(a) where the single exit price of a medicine or scheduled substance is less than ninety seven rand and six cents (R97.06), the dispensing fee shall not exceed R9.25 plus 46% of the single exit price in respect of that medicine or scheduled substance;
(b) where the single exit price of a medicine or scheduled substance is greater than or equal to ninety seven rand and six cents (R97.06) but less than two hundred and fifty eight rand and eighty eight cents (R258.88), the dispensing fee shall not exceed R22.50 plus 33% of the single exit price in respect of that medicine or scheduled substance;
(c) where the single exit price of a medicine or scheduled substance is greater than or equal to two hundred and fifty eight rand and eighty eight cents (R258.88) but less than nine hundred and six rand and ten cents (R906.10), the dispensing fee shall not exceed R69.00 plus 15% of the Single Exit Price in respect of that medicine or scheduled substance;
(d) where the single exit price of a medicine or scheduled substance is greater than or equal to nine hundred and six rand and ten cents (R906.10), the dispensing fee shall not exceed R160.00 plus 5% of the Single Exit Price in respect of that medicine or scheduled substance.
This fee which is exclusive of VAT represents a maximum dispensing fee and doesn’t preclude dispensers from charging a lower fee to be added to the SEP of a medicine or scheduled substance thus resulting in a final price to be paid by the consumer.
UPATED DISPENSING LAWS:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=128320199
Excellent!!!!
TXTM - TRANSPARENT PRICING SYSTEM FOR
MEDICINES AND SCHEDULED SUBSTANCES: DISPENSING FEE FOR
PHARMACISTS
This is another document I found.
http://www.gov.za/sites/www.gov.za/files/40577_gon48.pdf
TXTM Draft General medicines regulations
Anyone of you highly talented people know how to make sense of this document I found.
http://www.mccza.com/documents/d48cfaccGG40577MedicinesandrelatedSubstancesAct1965-DraftGeneralmedicineregulation.pdf
DRAFT GENERAL MEDICINE REGULATIONS 1/27/17.
Official document not yet released but I thought this was interesting.
http://www.mccza.com/documents/d48cfaccGG40577MedicinesandrelatedSubstancesAct1965-DraftGeneralmedicineregulation.pdf
Can anyone help decipher this document from 1/27/17? I believe its related to how to cannabinoids and other meds will be dispensed.
http://www.gov.za/sites/www.gov.za/files/40577_gon48.pdf
Medical Innovation Bill is before Parliament as of 1/27/17
http://www.parliament.gov.za/live/content.php?Category_ID=72
click on the word document updated as of 1/27/17 section E.
Great video. Green tea & Cannabis just the beginning.
This extraction technology is going to probably revolutionize the nutraceuticals industry as a whole.
I love the idea of this page.
Just FACTS being posted.
This is great.
Thanks Super Six
more like pound foolish!!!
Please read and state facts. its ok if you don't agree but be sure its based on facts and not lies.
This is just silly.
Tons of DD on this. Read the 1st sticky posted DD_dempsey.
or you can also find it on the below board too.
http://investorshub.advfn.com/THE-SUPER-SIX-31721/
MONOPOLY !!!! February is going to be Major!
I am really surprised at how little homework has been done on this board about this STOCK and how it relates to TXTM. Catch up people!! Understand what is actually happening. READ!!!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=128140657
This kind of info needs to be stickied.
Amazing work DD_dempsey.
Lots of DD on the SUPER SIX BOARD
http://investorshub.advfn.com/THE-SUPER-SIX-31721/
This is going to be epic!
Can't Wait to see what you've found DD_dempsey.
Puration and North American Cannabis Holdings to Reveal Huge Product Launch Event Where EVERx CBD Infused Bottle Water is Scheduled to Officially Launch
8:45 am ET January 24, 2017 (PR Newswire) Print
Puration, Inc. (USOTC: PURA) and North American Cannabis Holdings, Inc. (USOTC: USMJ) today announced that next week, on February 2, 2017, the two companies will reveal the major industry trade show where EVERx Cannabinoil (CBD) Infused Bottled Water will be officially launched.
"The launch event is going to be huge, and both USMJ and PURA have big roles to play" said Steven Rash, CEO of North American Cannabis Holdings. "An amazing ensemble of smart people and terrific organizations are coming together for what will be a tremendous launch event. When we tell you all about the EVERx launch event it will be crystal clear to you how USMJ and PURA fit together and how all the hard work getting to this launch has been worth it. EVERx is a winner and you will see it endorsed by winners at our launch event. You don't want to miss our announcement next week on Thursday, February 2nd and you don't want to miss our launch event in March. Put it on your calendar now."
"I first want to start by saying that Alkame Holdings' (USOTC: ALKM), was absolutely the right partner for PURA to pick for producing the EVERx CBD Infused Sports Drink with PURA's proprietary CBD extract." said Brian Shibley, CEO of Puration. "ALKM has been great. Not only is ALKM's patented water a perfect platform for PURA's proprietary CBD extract, the people at ALKM are simply the best kind of people to work with. They are committed to the mission; passionate about the mission and laser beam focused on the mission. EVERx CBD Infused Water is the best CBD infused water you can find. All of us at PURA, USMJ and ALKM can't wait to tell you about the product launch details. Just wait until you hear about the product launch plans on Thursday, next week. You're going to be excited too."
$3 Million First Year Revenue Plan
PURA has developed the EVERx CBD Infused Sports Drink with 10 mg of CBD in a 16.9 oz bottle. Based on an existing EVERx pre-order and the first distribution agreement, PURA anticipates $1 million in EVERx sales in 2017. PURA has published a comprehensive $3 million first year revenue plan for its overall product line.
PURA Proprietary CBD Extract and ALKM Water Technology
PURA's proprietary CBD extract process is combined with ALKM's patented technology that alters the structure of water, producing a combination of characteristics that are unprecedented in the beverage industry. The ALKM technology breaks down the hydrogen bonds, reducing water's cluster size, providing a more efficient delivery system for the CBD. Separate from the infused CBD, the ALKM technology includes an optimal alkaline pH level formulated with antioxidants and electrolytes for effective hydration.
EVERx CBD Infused Water Target Market
EVERx will target the growing number of recreational and competitive athletes citing CBD for its benefits in substantially reducing recovery times and increasing cardio output as well as accelerating the healing process from injury and preventing against future injury. EVERx will also target the general consumer that is becoming more aware of the antioxidant and neural- protective research backed benefits of CBD. Research has shown CBD to mitigate diabetes risk and reduce cancer cells among demonstrating other specific targeted uses.
CBD Benefits for Fitness and Wellness
CBD is an ideal component of a pre and post workout regime. CBD works as an anti-inflammatory and relieves muscle spasms. CBD also works to relieve pain. CBD protects the heart, lungs and brain. Often essential when it comes to high intensity and competitive training, CBD reduces nausea, increases appetite and aides sleep. Ongoing research continues in regard to CBD as a treatment for sports related head trauma. CBD is not just a good addition to an athletes training regime; It can be the foundation of a healthy wellness routine for everyone.
$279.65 Billion Bottled Water Market
The bottled water market was valued at US $157.27 billion in 2013 and is expected to reach US $279.65 billion by 2020 (Transparency Market Research). Given the magnitude of the bottled water market, management plans to review first quarter performance and potentially increase the first year target at that time.
To learn more about North American Cannabis Holdings: growusmj.com.
Follow the Company on Twitter: US_HEMP
To learn more about Puration: purationinc.com
Follow Puration on Twitter: Puration710
Visit Puration on Facebook: Facebook.com/puration/
To learn more about Alamke Holdings, Inc.: alkameholdingsinc.com
Disclaimer/Safe Harbor: This news release contains forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company's current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies' contracts, the companies' liquidity position, the companies' ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.
Steven Rash Phone: +1-972-528-0162 Email: Info@growusmj.com
Puration Contact: Brian Shibley, CEO info@purationinc.com +1-214-937-9097
SOURCE Puration, Inc. and North American Cannabis Holdings, Inc.
https://rt.prnewswire.com/rt.gif?NewsItemId=enUK201701249742&Transmission_Id=201701240845PR_NEWS_USPR_____enUK201701249742&DateId=20170124
Plandaí, entered into a 49-year notarial lease on an 8,000 acre agricultural estate South Africa....They are planning to be around for a long time with the extraction technology.
http://protecnutra.com/our-partners/plandai-biotechnology/
Plandai is positioning its self with distribution points in Europe, ASIA, North & South America and Africa
Just google Plandai distribution.
Medicines Control Council wishes to clarify the current framework for access to cannabis for medicinal purposes in South Africa
http://www.mccza.com/documents/5933cac110.14_Media_Release_Cannabis_Nov16_v1.pdf
Do your DD on PLPL .... important dates ahead
The new regulations on the use of cannabis sativa will be published by the end of January.
The use of high quality marijuana for prescribed medication will be legalized by February 2017, following efforts by the MCC to amend the Medicines and Related Substances Act
South Africa is set to legalize the cultivation and use of marijuana, locally called dagga, becoming the first nation in Africa to permit its medical use by April
TXTM.PLPL.South Africa to legalize MJ FEB 2017
http://afkinsider.com/135750/south-africa-legalize-medical-marijuana/
So is it just me or is this thing not trading today?
DANG!!!! DOES ANYONE KNOW WHAT IS GOING ON HERE?
HAPPY TO SEE THE ACTION HERE BUT WHY IS IT MOVING?
Wondering how TXTM and PLPL will be affected by new Cannabis regulations in S. Africa to be announced in February after reading this old article. Any Thought???
http://www.iol.co.za/news/politics/dagga-a-step-closer-to-being-legalised-in-sa-2092895